SM204 M-SERIES W/BIG WHEEL
Report
- Report Number
- 0001831750-2024-01390
- Event Type
- Malfunction
- Date Received
- October 31, 2024
- Date of Event
- October 2, 2024
- Report Date
- November 7, 2024
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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 REDUCED/INADEQUATE BRAKE FORCE FOR OUR STRETCHER LINES (PRODUCT CODE FPO), AS THIS HAZARD HAS NOT CAUSED OR CONTRIBUTED TO ANY SERIOUS INJURIES IN AT LEAST TWO YEARS. THE LAST SERIOUS ADVERSE EVENT MANUFACTURER REPORT #0001831750-2018-00587 WAS ORIGINALLY SUBMITTED ON OCTOBER 19TH, 2018. 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.
IT WAS REPORTED THAT THE BRAKE IS NOT HOLDING CAUSING REDUCED/INADEQUATE BRAKE FORCE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
IT WAS REPORTED THAT THE BRAKE IS NOT HOLDING CAUSING REDUCED/INADEQUATE BRAKE FORCE. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2067185 | SM204 M-SERIES W/BIG WHEEL | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |