FDA Adverse Event
Malfunction
Summary report: N
BARIMAX BED
MDR report key: 17526370
·
Received August 12, 2023
Report
- Report Number
- MW5133310
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- December 8, 2020
- Manufacturer
- BARI-MAX
- 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 ALLEGED A BARI-MAX BED, SERIAL NUMBER (B)(6) HAD A DAMAGED POWER CORD. (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 |
|---|---|---|---|---|---|---|---|
| 2234360 | BARIMAX BED | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | BARI-MAX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |