FDA Adverse Event
Other
Summary report: N
MAXI MOVE (AHE)
MDR report key: 1914333
·
Received November 12, 2010
Report
- Report Number
- 9611530-2010-00112
- Event Type
- Other
- Date Received
- November 12, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 27, 2010
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MFG BY ARJO HOSPITAL EQUIPMENT (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSP EQUIPMENT (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE USA, ARJOHUNTLEIGH INC, (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
AS STATED BY THE CUSTOMER (B)(6) 2010: PER THE AHUS SERVICE TECH - "RESIDENT WAS BEING TRANSFERRED FROM A WHEEL CHAIR TO A MAT IN REHAB BY (B)(6). THE SLING WAS NOT FULLY CLIPPED AND LET LOOSE ON ONE SIDE. THE RESIDENT FELL TO THE MAT ON HER SIDE." (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXI MOVE (AHE) | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJO HOSPITAL EQUIPMENT AB | KMB* |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR |