FDA Adverse Event
Malfunction
Summary report: N
CARROLL
MDR report key: 17537391
·
Received August 12, 2023
Report
- Report Number
- MW5144269
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- December 3, 2014
- Manufacturer
- INVACARE CORPORATION
- Product Code
- FNL
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE ORIGINAL EQUIPMENT MANUFACTURER OF THE REPORTED DEVICE. THE CUSTOMER REPORTED THAT A CARROLL BED, SERIAL NUMBER (B)(6) HAD A MALFUNCTIONING FOWLER ACTUATOR. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1049868 | CARROLL | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | INVACARE CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |