FDA Adverse Event
Other
Summary report: N
MAXIMOVE
MDR report key: 2111049
·
Received May 6, 2011
Report
- Report Number
- 9611530-2011-00037
- Event Type
- Other
- Date Received
- May 6, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 8, 2011
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
STNA WAS LIFTING THE RESIDENT FROM A SHOWER CHAIR INTO THE BED. THE RESIDENT SLIPPED OUT OF THE SLING FALLING FEET FIRST ONTO THE FLOOR FROM A HEIGHT OF ABOUT THREE FEET (HOWEVER, THE (B)(6) SAID ALL THE SLING CLIPS WERE STILL ATTACHED TO THE SPREADER BAR AFTER THE RESIDENT FELL). AS A RESULT OF THE INCIDENT, THE PT SUFFERED A LACERATION TO THEIR FOREHEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMOVE | PASSIVE FLOOR LIFT | FSA | ARJO HOSPITAL EQUIPMENT AB | KMBB4NLX2FUS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention |