FDA Adverse Event
Malfunction
Summary report: N
MAXI 500
MDR report key: 3111221
·
Received April 19, 2013
Report
- Report Number
- 1419652-2013-00100
- Event Type
- Malfunction
- Date Received
- April 19, 2013
- Report Date
- April 4, 2013
- Manufacturer
- ARJOHUNTLEIGH MAGOG INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
WITH A FLOOR LIFT, CERTIFIED NURSING ASSISTANT (CNA) WAS TRANSFERRING A RESIDENT FROM BED TO CHAIR. CNA WERE CHECKED THE CONNECTIONS. THE LOWER LEFT SLING CLIP WAS DETACHED AND THE RESIDENT SLID OUT AND HIT THEIR HEAD. X-RAYS WAS TAKEN BUT NO INJURIES WERE REPORTED. MFR #: 9681684-2013-00037.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168681 | MAXI 500 | MANUFACTURED FLOOR PASSIVE LIFT | FSA | ARJOHUNTLEIGH MAGOG INC. | KM560181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |