FDA Adverse Event
Malfunction
Summary report: N
BASIC CONFIGURATION MODEL 6100 BASE
MDR report key: 2861815
·
Received November 8, 2012
Report
- Report Number
- 1831750-2012-11678
- Event Type
- Malfunction
- Date Received
- November 8, 2012
- Date of Event
- October 14, 2012
- Report Date
- October 14, 2012
- Manufacturer
- STRYKER MEDICAL
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
UNIT WAS EVALUATED BY THE CUSTOMER. MANUFACTURER'S INVESTIGATION IS STILL ONGOING, IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT MAY BE SUBMITTED.
Description of Event or Problem · 1
OUR CUSTOMER REPORTED TO OUR TECHNICIAN THAT THE COT LEGS WOULD NOT LOCK. THERE WAS NO PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BASIC CONFIGURATION MODEL 6100 BASE | WHEELED, STRETCHER | FPO | STRYKER MEDICAL | 6100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |