6257 XPEDITION HIGH CONFIG

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 2 DEVICES WERE FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICES WERE REPAIRED AND RETURNED TO USE. 1 DEVICE IS PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Description of Event or Problem

THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INADEQUATE PATIENT RESTRAINT. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Description of Event or Problem

NO NEW INFORMATION.

Additional Manufacturer Narrative

THE DEVICE THAT WAS PENDING EVALUATION WAS NOT MADE AVAILABLE BY THE CUSTOMER; THE REPORTED ISSUE WAS NOT CONFIRMED. EVALUATION RESULTS FINDINGS (RESULTS/COMPONENTS). 1 DEVICE: NO FINDINGS AVAILABLE/APPROPRIATE TERM/CODE NOT AVAILABLE.

Description of Event or Problem

NO NEW INFORMATION.

Additional Manufacturer Narrative

IN ACCORDANCE WITH THE ¿FINAL GUIDANCE ON MEDICAL DEVICE REPORTING FOR MANUFACTURERS¿ ISSUED ON NOVEMBER 7, 2016, STRYKER MEDICAL WILL NO LONGER REPORT THE HAZARD OF INADEQUATE PATIENT RESTRAINT FOR OUR STAIR CHAIR LINES (PRODUCT CODE ILK), AS THIS HAZARD HAS NOT CAUSED OR CONTRIBUTED TO ANY SERIOUS INJURIES. WHILE NO NEW MDRS WILL BE GENERATED FOR THIS HAZARD MOVING FORWARD, ADDITIONAL SUPPLEMENTAL RECORDS MAY BE SUBMITTED FOR PAST REPORTED EVENTS IF NEW INFORMATION BECOMES AVAILABLE. SHOULD A NEW SERIOUS ADVERSE EVENT OCCUR ATTRIBUTED TO THIS HAZARD, MDR REPORTING WILL RESUME.