FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2112920
·
Received May 25, 2011
Report
- Report Number
- 1824206-2011-02848
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- October 1, 2010
- Report Date
- October 1, 2010
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN REPLACED THE TREND VALVE UNIT TO RESOLVE THE ISSUE. THIS MDR IS A RESULT OF CAPA ACTIVITY FOR THE RETROSPECTIVE REVIEW OF COMPLAINTS.
Description of Event or Problem · 1
INFORMATION RECEIVED INDICATES DRIFT IN THE HEAD HI/LOW FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | P1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |