6257 XPEDITION HIGH CONFIG

Description of Event or Problem

THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INADEQUATE PATIENT RESTRAINT. THERE WAS NO PATIENT INVOLVEMENT.

Additional Manufacturer Narrative

1 PENDING DEVICE WAS NOT EVALUATED BUT REVIEWED BY DATA AND CONFIRMED THE ISSUE. SECTION H CODES HAVE BEEN UPDATED.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS NOT EVALUATED AS THE CAUSE WAS DETERMINED BY ANALYZING DATA PROVIDED BY THE USER/THIRD PARTY; NO FURTHER ASSISTANCE WAS REQUESTED BY THE CUSTOMER. 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 2 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INADEQUATE PATIENT RESTRAINT. THERE WAS NO PATIENT INVOLVEMENT.