FDA Adverse Event
Malfunction
Summary report: N
MODEL 722 STRETCHER
MDR report key: 2722502
·
Received September 1, 2009
Report
- Report Number
- 1831750-2009-01840
- Event Type
- Malfunction
- Date Received
- September 1, 2009
- Manufacturer
- STRYKER MEDICAL
- Product Code
- INK
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: BY MERIT OF THE MEDICAL DEVICE CORRECTION NOTICE, THE SUMMARY IS TO REPLACE THE BUSHINGS.
Description of Event or Problem · 1
WE PURCHASE STRETCHER BASES FROM STRYKER MEDICAL AND COMBINE THEM WITH OUT TOP TO PRODUCE ARE CART THAT IS USED FOR SHOWER BATHING HOSPITAL PATIENTS. (B)(6), 2009 STRYKER MEDICAL SENT TO US A MEDICAL DEVICE CORRECTION NOTICE. THE NOTICE STATED THAT A BUSHING IN THE BRAKING SYSTEM MAY FRACTURE, WHICH COULD RESULT IN THE BRAKE/STEER PEDAL SIZING. THIS COULD RESULT IN THE BRAKE SYSTEM BECOMING INOPERABLE. ALSO REFER TO REPORT NUMBERS: 1831750-2009-01838, 1831750-2009-01839, 1831750-2009-01841.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODEL 722 STRETCHER | NONE | INK | STRYKER MEDICAL | 722 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |