FDA Adverse Event
Malfunction
Summary report: N
V4 I
MDR report key: 1993139
·
Received February 11, 2011
Report
- Report Number
- 9681684-2011-00011
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- January 16, 2011
- Report Date
- January 17, 2011
- Manufacturer
- BHM MEDICAL, INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE LIFT WAS RETURNED TO THE MANUFACTURER TO BE INSPECTED AND REPAIRED, IF NEEDED. THE INSTALLATION WAS INSPECTED AND REPAIRED BY A CERTIFIED TECHNICIAN. FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
THE FACILITY STAFF WAS BUSY PREPARING THE ENVIRONMENT OF ROOM #506 IN ORDER TO PUT TO BED THE RESIDENT WHO WAS NOT IN THE ROOM AT THAT TIME. THE STAFF OPENED THE BED AND MOVED THE CEILING LIFT CLOSER TO BE READY FOR THE TRANSFER. BY DOING THOSE ACTIONS SIMULTANEOUSLY, SHE DID NOT NOTICE THAT THE CEILING LIFE DID NOT STOP BY ITSELF. THE CEILING LIFT FELL ON THE GROUND. NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V4 I | LIFT, PATIENT, NON AC POWERED | FSA | BHM MEDICAL, INC. | 9110009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |