6257 XPEDITION HIGH CONFIG

Additional Manufacturer Narrative

THE DEVICE THAT WAS PENDING EVALUATION WAS NOT MADE AVAILABLE BY THE CUSTOMER; THE REPORTED ISSUE WAS NOT CONFIRMED. SECTION H CODES HAVE BEEN UPDATED TO REFLECT THIS.

Description of Event or Problem

NO NEW INFORMATION.

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE WAS 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 2 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICES EXPERIENCED INADEQUATE PATIENT RESTRAINT. THERE WAS NO PATIENT INVOLVEMENT.