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1. r pa r a A f H H akis ETS Immediate Actions Ei Ee SS M ENAS AEA LEAN gt re The devices may continue to be used providing that the following instructions are followed 1 Immediately locate all devices and ensure that users are made aware of this action 2 Place a copy of the FSN in a prominent place where users of the device will be reminded of the action 3 Maintain awareness of this of this notice internally until all required actions have been completed within your facility 4 inform Stryker if any devices have been further distributed to other locations Please provide contact information so that Stryker can contact the new users directly 5 Inform Stryker if there have been any issues associated with use or attempted use of subject devices 6 Comply with any local regulations on concerning notification of adverse events to National Competent Authorities 7 Complete customer response form and return to Stryker Please complete even if you no longer have any of the subject devices 5 f aS 8 On receipt of the customer response form a Stryker representative will contact you to arrange for upgrade of units Complete the attached customer response form please complete this form even if you do not have any product to return This will preclude the need to Stryker to send any reminder notices Return the completed form to A Stryker representative will then contact you to organise return of subjec
2. of the above listed product Contact Name 1 Complete and fax back this form to Stryker 2 A Stryker Representative will call you to arrange collection of product upgrade if necessary 3 Please ensure that the outer package is labelled with Stryker RA Reference number 4 Ensure that forms are secured in a document wallet on the outer of the package 5 Please ensure that where appropriate a decontamination certificate is returned with product RA2009 406 EMEA CA Notification FINAL
3. Stryker Europe Middle East amp Africa Regus Les Espaces de Sophia Our manufacturer has notified us of a Product Field Action concerning the Medical Devices referenced below Our records indicate that you have been supplied with some of the subject devices We would request therefore that you read this notice carefully and follow the instructions provided by the manufacturer We would like to reassure you that only the devices listed are affected by this action On behalf of Stryker we would like to thank you in advance for your cooperation and support in this matter Please note that in accordance with the Medical Device Directive and the Meddev Vigilance Guidance Document this Field Safety Corrective Action has been notified to the National Competent Authority of all countries where subject devices have been distributed This Field Safety Notice has been issued in accordance with the European Competent Authority detailed below Date of report 2010 05 28 Stryker Internal Reference Number RA2009 406 Name of Manufacturer Stryker Communications Website address www stryker com National Competent Authority if appropriate please delete if not Regulatory Agency Reference No if appropriate please delete if not Local Contact Information Contact Person Contact tel number Contact e mail Product Information payee EELE oF heel Ie r sa N Ae re eran ERV cs ENN PAPERA pk Bus ve Et ar oe TE ool a eg IT Product Des
4. cription SwitchPoint Infinity 2 amp SwitchPoint Element DOM Cards Product Code Catalogue No from 0100224307 SPI2 DOM Card 0100224592 SPE DOM Card Product Code Catalogue No to 0100224307 SPI2 DOM Card 0100224592 SPE DOM Card Lot Numbers All units distributed between 23 MAR 07 and 14 AUG 09 Software version if applicable 0 Quantities distributed to your facility Expiration date of product Not Applicable Expected shelf life product life Not Applicable Complaints were received reporting that DOM cards were failing and causing the inability to re route video in the operating room Population concerned Patients where device is being used RA2009 406 EMEA CA Notification FINAL Potential Hazards associated with use of device 4 Inability to change video routes and hospital staff is unable acquire an alternate means to display video resulting in a possible delay to the start of patient treatment Inability to change video routes and hospital staff is unable acquire an alternate means to display video resulting in a possible delay to surgery of lt 30 minutes or less and possible additional exposure of the patient to additional anaesthesia Inability to change routes and hospital staff is unable to acquire an alternate means to display video resulting in a prolongation of patient treatment of 30 or more minutes Inability to change video routes and hospital staff is unable to acquire an alternate means to display video resu
5. lting in the conversion to an open procedure resulting in a possible prolongation of patient treatment of 30 or more minutes Mitigating circumstances precautionary measures The occurrence of this failure has been classified as remote However in the event that a drive on module failure is experienced by the user the following may be seen Page Not Found error message Missing drop down options A frozen touch panel lf this failure occurs whilst the unit is operational the existing video image will not be affected In the event that this does occur during a procedure the user can utilise the video backup video safety pass through feature Specific advice for surgeons regarding patients with implanted devices Not Applicable Communicatlona ARAchn isis 5a E E ES E EE S ass EA LE aaa UPAS Shen A EEN h UA EN ERN OANRET RA Customer response form Indicate number of pages IFU User manual Operative Technique Indicate number of pages Upgrade kit indicate nature of kit Labas T TA aA aaa SaaS Waa eae RAC eS IE iy 5S 2s Ses D0 tp jet ty f Mag he r CERA A O an INSE at An a a ET BOSSE pact oN Paly Ps eg Ree pw key bel COE Sem AOR ar Wl Ries 5 a PG tee Sen a Set i N s f 4 la S2 u qrah al A aw we a ery AFAR a nE N SS Oe oS DADS am Lt A gt ee oe ay Se ed SZ Dist Pt ot ee a e ee ab Sa ss Fe A SV 7 O T AN Aa S e E N tr rn ee R a Cee Scr ih ra aa te MA w i 4 Te 2 3
6. t devices RA2009 406 EMEA CA Notification FINAL Lot Serial Numbers All units distributed between 23 MAR 07 and 14 AUG 09 i T 7 l have checked inventory and completed the product disposition table A Please sign and return this form to acknowledge receipt of product notice Name of Hospital Organisation Completion Instructions CUSTOMER RESPONSE FORM Please complete this form even if you do not have any product to return This will preclude the need for future notices Stryker RA Reference Number RA2009 406 Pe eee er ee Product Description SwitchPoint Infinity 2 amp SwitchPoint Element DOM Cards 0100224307 SPI2 DOM Card 0100224592 SPE DOM Card 0100224307 SPI2 DOM Card 0100224592 SPE Please check your inventory for affected product and return completed form to our Quality Department as soon as possible Please note only the product codes catalogue numbers specified are affected by this action Product Disposition Completed by Customer _ Product Code Cat No Qty to be Qty not Upgraded returned _ o mal a itt eT id oft T SM Fi talus 4 a z gt We Mes LI aA pe wy sir Customer Details Response requirements please complete delete appropriate section have checked inventory and can confirm that we do not have any affected product at this location Please have Stryker service contact our maintenance department to arrange upgrade

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