FDA Adverse Event
Injury
Summary report: N
MAXI MOVE (AHE)
MDR report key: 1750714
·
Received July 2, 2010
Report
- Report Number
- 9611530-2010-00030
- Event Type
- Injury
- Date Received
- July 2, 2010
- Date of Event
- June 14, 2010
- Report Date
- June 16, 2010
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE ARE REPORTING ACCORDING TO EXEMPTION (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION. TRACK WISE ID.
Description of Event or Problem · 1
AS STATED BY THE CUSTOMER 2010-06-16: DURING TRANSFER FROM THE RESIDENT'S BATHROOM TO BED, PT FELL FROM THE LIFTER LANDING ON FLOOR. (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 | 73 YR | Hospitalization |