FDA Adverse Event
Malfunction
Summary report: N
HOYER 600
MDR report key: 1996023
·
Received January 24, 2011
Report
- Report Number
- 9681684-2011-00009
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Report Date
- January 5, 2011
- Manufacturer
- BHM MEDICAL, INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFORMATION WILL BE PROVIDED UPON MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
DURING A TRANSFER FROM A CHAIR TO ANOTHER CHAIR, WHILE THE PATIENT WAS SUSPENDED AND LIFTED BY THE HOYER-600, THE BOTTOM PART OF THE SPREADER BAR DETACHED. THE PATIENT FELL THREE FEET DIRECTLY TO THE GROUND, HOWEVER, IT WAS REPORTED THAT SHE DID NOT SUSTAIN ANY INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOYER 600 | LIFT, PATIENT, NON AC POWERED | FSA | BHM MEDICAL, INC. | 9600131.06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Other |