FDA Adverse Event
Malfunction
Summary report: N
ADVANTA BED
MDR report key: 3071078
·
Received April 8, 2013
Report
- Report Number
- 1824206-2013-01985
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 11, 2013
- Report Date
- March 11, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN REPLACED THE HEAD AND FOOT SENSOR STRIPS TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
CUSTOMER ALLEGED THE (B)(4) WOULD SET BUT NOT ALARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144439 | ADVANTA BED | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |