FDA Adverse Event
Malfunction
Summary report: N
CCU BED
MDR report key: 1821801
·
Received August 26, 2010
Report
- Report Number
- 1824206-2010-09604
- Event Type
- Malfunction
- Date Received
- August 26, 2010
- Date of Event
- August 3, 2010
- Report Date
- August 3, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH ISOLATED THE UNINTENTIONAL MOVEMENTS TO THE LOCKOUT BOARD. THE ACCOUNT DECLINED TO HAVE THE BED REPAIRED.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE BED HAS UNINTENTIONAL MOVEMENTS INTERMITTENTLY. IT MAY TAKE A MONTH OR SO FOR THE ISSUE TO DUPLICATE OR RETURN. NO INJURY REPORTED. BED IS ONLY USED AS A BACKUP BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CCU BED | AC POWERED HOSPITAL BED | FNL | HILL-ROM INC. | 894 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |