FDA Adverse Event
Other
Summary report: N
BASIC CONFIGURATION MODEL 6500
MDR report key: 2141552
·
Received June 17, 2011
Report
- Report Number
- 1831750-2011-06142
- Event Type
- Other
- Date Received
- June 17, 2011
- Date of Event
- May 17, 2011
- Report Date
- May 20, 2011
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ALLEGED COT COLLAPSE WAS REPORTED WHEN BEING USED IN A HYPERBARIC CHAMBER, 11 METERS UNDER SEA LEVEL (PRESSURE : 1 ATM).
Description of Event or Problem · 1
A CUSTOMER REPORTED THROUGH OUR DISTRIBUTOR THAT THE COT WAS PLACED IN A HYPERBARIC CHAMBER, 11 METERS UNDER SEA LEVEL (PRESSURE : 1 ATM) AND COLLAPSED FROM THE HIGHEST LEVEL TO THE LOWEST ONE. WHEN THE PRODUCT WAS PLACED IN A NORMAL PRESSURE ENVIRONMENT, THE COT WORKED PROPERLY. THERE WAS REPORTED PT INVOLVEMENT, HOWEVER, NO ADVERSE CONSEQUENCES WERE REPORTED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASIC CONFIGURATION MODEL 6500 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL | 6500 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |