FDA Adverse Event
Malfunction
Summary report: N
MULTICARE LE
MDR report key: 5406395
·
Received February 3, 2016
Report
- Report Number
- 5406395
- Event Type
- Malfunction
- Date Received
- February 3, 2016
- Date of Event
- November 29, 2015
- Report Date
- January 27, 2016
- Manufacturer
- LINET AMERICAS INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
KNEE DRIVE RAM MOTOR MALFUNCTION. DRIVE ARM BENT AND BENT BRACKET OF 3/16" STEEL. MANUFACTURER RESPONSE FOR LINET MC BED, LINET MC LE BED (PER SITE REPORTER): LINET WILL SEND A REP TO REPLACE FRAME OF BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 65918 | MULTICARE LE | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | LINET AMERICAS INC. | IMC5A650 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |