FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE PULMONARY SURFACE
MDR report key: 1850108
·
Received September 28, 2010
Report
- Report Number
- 1824206-2010-10157
- Event Type
- Malfunction
- Date Received
- September 28, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 1, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ACCOUNT REPLACED THE HYDRAULIC BLOCK AND THE PROBLEM IS RESOLVED.
Description of Event or Problem · 1
ACCOUNT ALLEGES, THE BED HAS A SLOW DRIFT AT THE HI/LOW HEAD SECTION. NO INJURIES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE PULMONARY SURFACE | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | P1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |