FDA Adverse Event
Malfunction
Summary report: N
FREEDOM 500
MDR report key: 7133521
·
Received December 20, 2017
Report
- Report Number
- 3009591865-2017-00004
- Event Type
- Malfunction
- Date Received
- December 20, 2017
- Date of Event
- July 25, 2016
- Report Date
- December 18, 2017
- Manufacturer
- UMANO MEDICAL INC
- Product Code
- FNL
- UDI-DI
- 00670482000081
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS ALLEGED THAT A BED MODEL FM500 WAS FOUND WITH A SUPPORT ARM DISASSEMBLED FROM A FOOTEND RAIL. THE BED WAS NOT IN SERVICE, THE SITUATION WAS NOTICED DURING INSPECTION OF BED. THERE WERE NO REPORTED ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 914580 | FREEDOM 500 | MEDICAL BED | FNL | UMANO MEDICAL INC | FM500 | 00670482000081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |