FDA Adverse Event
Malfunction
Summary report: N
ADVANTA BED
MDR report key: 2221740
·
Received August 17, 2011
Report
- Report Number
- 1824206-2011-04349
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 2, 2011
- Report Date
- August 2, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT COULDN'T' REMEMBER WHAT WAS DONE TO RESOLVE THE ISSUE, BUT BELIEVES WHEN THE LOGIC BOARD WAS REPLACED IT REPAIRED THE BED.
Description of Event or Problem · 1
THE ACCOUNT STATED WHILE THE BED WAS SITTING IDLE, THE HI/LOW FUNCTION UNINTENTIONALLY RAN DOWN A LITTLE AND THE HEAD AND KNEE MOTORS WILL JERK BUT DO NOT MOVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVANTA BED | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |