POWER PRO AMBULANCE COT
Report
- Report Number
- 0001831750-2021-01155
- Event Type
- Malfunction
- Date Received
- July 27, 2021
- Date of Event
- April 1, 2021
- Report Date
- October 27, 2021
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- UDI-DI
- 07613327261639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO DOCUMENT AN EVENT THAT WAS NOT PREVIOUSLY CAPTURED AS THE DEVICE IS STILL PENDING EVALUATION.
THE FINAL 4 INVESTIGATIONS HAVE BEEN COMPLETED. 1 DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED ON SITE AND RETURNED TO SERVICE. 1 DEVICE WAS EVALUATED IN THE FIELD AND IT WAS DETERMINED THE MALFUNCTION WAS CAUSED BY THE FASTENER AND NOT THE COT, AND THEREFORE IS NOT REPORTABLE. THIS EVENT HAS BEEN REMOVED FROM THE NUMBER OF EVENTS SUMMARIZED. 1 DEVICE WAS EVALUATED IN THE FIELD AND IT WAS DETERMINED THE DEVICE WAS NOT EXPERIENCING THIS ISSUE. THIS EVENT HAS BEEN REMOVED FROM THIS SUMMARY REPORT AND ADDED TO THE FINAL NUMBER OF EVENTS SUMMARIZED UNDER MFG REPORT # 0001831750-2021-01259 1 DEVICE WAS EVALUATED IN THE FIELD AND UPON COMPLETION OF THE INVESTIGATION, IT WAS DETERMINED THIS DEVICE WAS ALSO EXPERIENCING AN ADDITIONAL DEVICE PROBLEM NOT PREVIOUSLY REPORTED. THIS EVENT HAS BEEN REMOVED FROM THIS REPORT AND DOCUMENTED SEPARATELY UNDER MFG REPORT # 0001831750-2021-01347.
THE NUMBER OF EVENTS HAS BEEN UPDATED TO INCLUDE AN EVENT PREVIOUSLY REPORTED IN MFR REPORT # 0001831750-2021-01259 FOLLOWING THE COMPLETION OF AN INVESTIGATION. THE DEVICE WAS EVALUATED IN THE FIELD BUT THE ISSUE WAS NOT CONFIRMED; NO DEFECT OR MALFUNCTION WAS FOUND. 1 DEVICE WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED ON SITE AND RETURNED TO SERVICE. 1 DEVICE WAS EVALUATED IN THE FIELD BUT THE ISSUE WAS NOT CONFIRMED; NO DEFECT OR MALFUNCTION WAS FOUND.
THE FINAL DEVICE WAS EVALUATED IN THE FIELD, BUT THE ISSUE WAS NOT CONFIRMED; NO DEFECT OR MALFUNCTION WAS FOUND.
THIS REPORT SUMMARIZES 85 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULTY LOADING/UNLOADING THE COT IN THE AMBULANCE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED PAIN.
THIS REPORT SUMMARIZES 84 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULTY LOADING/UNLOADING THE COT IN THE AMBULANCE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED PAIN.
THIS REPORT SUMMARIZES 87 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULTY LOADING/UNLOADING THE COT IN THE AMBULANCE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED PAIN.
THIS REPORT SUMMARIZES 85 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULTY LOADING/UNLOADING THE COT IN THE AMBULANCE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED PAIN.
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 79 DEVICES WERE FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICES WERE REPAIRED AND RETURNED TO USE. 1 DEVICE WAS NOT EVALUATED AND NO CAUSE WAS DETERMINED, AS THE CUSTOMER DID NOT MAKE THE DEVICE ACCESSIBLE FOR TESTING. 6 DEVICES ARE PENDING EVALUATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.
THIS REPORT SUMMARIZES 86 MALFUNCTION EVENTS, WHERE IT WAS REPORTED THE DEVICES EXPERIENCED DIFFICULTY LOADING/UNLOADING THE COT IN THE AMBULANCE. THERE WAS 1 EVENT WITH PATIENT INVOLVEMENT; THE PATIENT EXPERIENCED PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1130162 | POWER PRO AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO | 6506 | 07613327261639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |