FDA Adverse Event
Malfunction
Summary report: N
MX-PRO R-3 AMBULANCE COT
MDR report key: 3150408
·
Received June 6, 2013
Report
- Report Number
- 0001831750-2013-05141
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 10, 2013
- Report Date
- May 10, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THIS IS A DUPLICATE OF MFR REPORT # 0001831750-2013-05100. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 6082000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 0001831750-2013-05100FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 6082000000 FOR THIS COMPLAINT.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE COT IS LEANING DUE TO A BENT X-FRAME. THE OUTER LIFT TUBES ARE CRACKED PREVENTING THE COT FROM LOWERING. 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 |
|---|---|---|---|---|---|---|---|
| 250101 | MX-PRO R-3 AMBULANCE COT | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |