FDA Adverse Event
Malfunction
Summary report: N
MX-PRO R-3 AMBULANCE COT
MDR report key: 3013916
·
Received March 20, 2013
Report
- Report Number
- 0001831750-2013-02258
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Date of Event
- February 21, 2013
- Report Date
- February 21, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO REPAIR WAS MADE BY THE FIELD TECHNICIAN AS THE ALLEGED ISSUE WAS UNABLE TO BE DUPLICATED. THE ALLEGED ISSUE WAS RESOLVED FOR THE CUSTOMER BY THE FIELD TECHNICIAN INSTRUCTING THE CUSTOMER HOW TO PROPERLY RAISE AND LOWER THE COT.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE COT WAS NOT LATCHING WHEN RAISED UP. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE COT WAS NOT LATCHING WHEN RAISED UP. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED. THE COT WAS NOT LATCHING WHEN RAISED UP
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115889 | MX-PRO R-3 AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |