6257 XPEDITION HIGH CONFIG
Received Jan 24, 2024 · Event occurred Oct 1, 2023
Report 0001831750-2024-00203 · MDR key 18573179
Device
Generic name
Transport, Patient, Powered
Manufacturer
Stryker Medical-kalamazooCatalog number
625705550002
Product problems
- Difficult to Fold, Unfold or Collapse
- Difficult to Fold, Unfold or Collapse
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THIS REPORT SUMMARIZES 0 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO FOLD/UNFOLD . THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
THE DEVICE THAT WAS PENDING WAS EVALUATED IN THE FIELD BUT THE ISSUE WAS NOT CONFIRMED; NO DEFECT OR MALFUNCTION WAS FOUND. SECTION H CODES HAVE BEEN UPDATED. BECAUSE OF THIS, THE NUMBER OF REPORTED EVENTS HAS BEEN CHANGED FROM 1 TO 0.
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 ISSUE WAS IDENTIFIED AND RESOLVED THROUGH COMMUNICATION/INTERVIEWS WITH THE USER FACILITY; NO DEFECT OR MALFUNCTION WAS FOUND. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.
Description of Event or Problem
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT, WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO FOLD/UNFOLD. THERE WAS NO PATIENT INVOLVEMENT.