FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE-TREAT SURFACE&SCALE TOTAL CARE FRAME
MDR report key: 1488671
·
Received August 11, 2009
Report
- Report Number
- 1824206-2009-04354
- Event Type
- Malfunction
- Date Received
- August 11, 2009
- Date of Event
- March 13, 2008
- Report Date
- March 13, 2008
- Manufacturer
- HILL-ROM RITTER
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECH FOUND HILOW HEAD CYLINDER APPARENTLY BAD. TECH REPLACED HILOW HEAD CYLINDER. NO VISUAL EVIDENCE OF DRIFTING AFTER REPAIR. TECH PLACED BED BACK INTO SERVICE. HILL-ROM IS CONTINUING ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY. THIS EFFORT WILL CONTINUE UNTIL WE ARE CURRENT.
Description of Event or Problem · 1
CUSTOMER STATES THE HEAD HILOW CYLINDER IS DRIFTING DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE-TREAT SURFACE&SCALE TOTAL CARE FRAME | AC POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM RITTER | P1900H006202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |