LATERAL PROTECTION EU, PAIR

Additional Manufacturer Narrative

GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). AT THE TIME OF THIS REPORT THE INVESTIGATION WAS STILL ONGOING. AS SOON AS THE INVESTIGATION IS FINISHED THE REPORT WILL BE UPDATED AND A FOLLOW-UP/FINAL REPORT WILL BE PROVIDED TO THE FDA.

Description of Event or Problem

IT WAS REPORTED THAT THE LATERAL PROTECTION WAS JAMMED AND DIFFICULT TO RELEASE. WHILE TRYING TO RELEASE A LOCKING ELEMENT, THE USER SLIPPED AND CUT HIS THUMB ON A SHARP EDGE. HE REQUIRED STITCHES AND A TETANUS VACCINATION. (B)(4).

Additional Manufacturer Narrative

THE AFFECTED LATERAL PROTECTION WAS INVESTIGATED WITH THE FOLLOWING RESULT. A SHARP EDGE AT THE PRODUCT COULD NOT BE FOUND. THE CHAMFER AT THE EDGE ON WHICH THE USER HAS CUT HIMSELF IS AS SPECIFIED IN THE MANUFACTURING DOCUMENTATION. THE INVESTIGATION REVEALED THAT THE RELEASE MECHANISM CONNECTED TO THE LOCKING ELEMENT WAS DIFFICULT TO OPERATE. THE LOCKING ELEMENT IS A BUTTON. BESIDE THE BUTTON A BEARING IS PART OF THE RELEASE MECHANISM. THIS BEARING WAS DEFORMED AT THE AFFECTED PRODUCT. DUE TO THIS DEFORMATION THE RELEASE MECHANISM WAS DIFFICULT TO OPERATE. BESIDES THE DEFORMATION OF THE BEARING, SIGNS OF USE, SCRATCHES AND IMPACT POINTS WERE FOUND. WE ASSUME THAT THE DEFORMATION AT THE BEARING WAS CAUSED BY ROUGH HANDLING AND/OR BY OVERLOAD OR INCORRECT LOADING. THE PRODUCTION RECORDS OF THE AFFECTED PRODUCT WERE CHECKED AND NO DEVIATIONS WERE FOUND. IN THE INSTRUCTIONS FOR USE (IFU) THE MAXIMUM APPLICABLE LOAD FOR THIS PRODUCT IS STATED. BESIDES, IT IS MENTIONED IN THE IFU THAT THE PRODUCT IS NOT INTENDED TO BE USED AS PATIENT SUPPORT. FURTHERMORE IT IS STATED IN THE IFU THAT THE PRODUCT SHOULD ONLY BE OPERATED IF IT IS FULLY FUNCTIONAL AND THAT THE USER IS OBLIGATED TO CHECK THE PRODUCT PRIOR TO USE, TO ENSURE IT IS FULLY FUNCTIONAL AND IN GOOD WORKING ORDER. PRIOR TO EACH USE A FUNCTIONAL AND VISUAL INSPECTION HAVE TO BE PERFORMED. IN CASE DAMAGES TO MECHANICAL PARTS, LIKE THE DEFORMATION AT THE BEARING MENTIONED ABOVE, ARE FOUND DURING THIS CHECK THE PRODUCT MUST NOT BE USED. THE SAME APPLIES IN CASE IT IS NOT POSSIBLE TO OPERATE AN ADJUSTMENT FUNCTION. WE ASSUME THAT THE USER SLIPPED WHEN HE TRIED TO OPERATE THE RELEASE MECHANISM, SINCE IT WAS DIFFICULT TO OPERATE. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

Description of Event or Problem

MANUFACTURER REFERENCE # (B)(4).