FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE PULMONARY SURFACE BED
MDR report key: 2972157
·
Received January 22, 2013
Report
- Report Number
- 1824206-2013-00630
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 9, 2013
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN INSPECTED ALL BED FUNCTIONS AND FOUND ALL MATTRESS PRESSURES AND SETTINGS TO BE AS SPECIFIED WITH NO SURFACE DAMAGE. THE MATTRESS TICKING WILL BE REPLACED UNDER WARRANTY.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE SILVER SURFACES OF THE MATTRESS ARE CAUSING THE STAFF BACK PAIN IMMEDIATELY AFTER PT POSITIONING. NO INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31672 | TOTALCARE PULMONARY SURFACE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |