FDA Adverse Event
Malfunction
Summary report: N
MAXI TWIN
MDR report key: 2110991
·
Received April 29, 2011
Report
- Report Number
- 9611530-2011-00032
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 1, 2011
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT A CLIENT WAS BEING LIFTED IN THE SLING ATTACHED TO A MAXI TWIN AND THE LEFT HAND LEG STRAP OF SLING BECAME DISENGAGED. THE CLIENT THEN SLIPPED FROM THE SLING TO THE FLOOR FROM A HEIGHT OF APPROX 4 FEET. CLIENT HAS BEEN TAKEN TO HOSPITAL AND IS NOW RETURNING TO SITE; PT SUFFERED A SKIN GRAZE AND SOME BRUISING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXI TWIN | PASSIVE FLOOR LIFT | FSA | ARJO HOSPITAL EQUIPMENT AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other |