FDA Adverse Event
Malfunction
Summary report: N
MAXIMOVE
MDR report key: 2238441
·
Received August 29, 2011
Report
- Report Number
- 9681684-2011-00060
- Event Type
- Malfunction
- Date Received
- August 29, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 3, 2011
- Manufacturer
- BHM MEDICAL, INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION #(B)(4)) ON BEHALF OF THE MFR BHM MEDICAL, INC (REGISTRATION #(B)(4)). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
DURING A PT TRANSFER TO A WHEELCHAIR, THE UPPER LEFT SLING CLIP CAME OFF AND THE PT SLIPPED OUT OF THE SLING THAT WAS ATTACHED TO THE MAXIMOVE LIFT AND FELL TO THE FLOOR. THE CAREGIVER SUPPORTED THE PT'S HEAD TO PREVENT INJURY. THE PT WAS SENT TO ER FOR EVAL AND NO INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMOVE | MANUFACTURED FLOOR PASSIVE LIFT | FSA | BHM MEDICAL, INC. | KMCSUN-D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Other |