FDA Adverse Event
Malfunction
Summary report: N
EZ-PRO 2 AMBUL COT OBS 1/00
MDR report key: 3233944
·
Received July 18, 2013
Report
- Report Number
- 0001831750-2013-06452
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 24, 2013
- Report Date
- June 24, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THAT THE COT WILL NOT UNLOCK. THIS INFORMATION WAS REPORTED IN ERROR, THERE WAS NO ISSUE WHIT THIS UNIT NOT BEING ABLE TO UNLOCK.
Description of Event or Problem · 1
IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE COT WILL NOT UNLOCK. 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 WILL NOT UNLOCK. 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 |
|---|---|---|---|---|---|---|---|
| 333501 | EZ-PRO 2 AMBUL COT OBS 1/00 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |