FDA Adverse Event
Malfunction
Summary report: N
HOYER 600
MDR report key: 2467597
·
Received February 17, 2012
Report
- Report Number
- 9681684-2012-00013
- Event Type
- Malfunction
- Date Received
- February 17, 2012
- Date of Event
- November 29, 2011
- Report Date
- January 19, 2012
- Manufacturer
- ARJOHUNTLEIGH MAGOG
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION# 1419652) ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4) (REGISTRATION# 9681684). (B)(4) IS THE IMPORTER FOR THIS DEVICE AND HAS SUBMITTED REPORT #2182305-2011-00052. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED TO THE MFR BY THE IMPORTER OF THE DEVICE THAT AN INCIDENT OCCURRED INVOLVING A FLOOR LIFT. AS REPORTED TO THE IMPORTER PER THE FACILITY, THE HANGER BAR DETACHED WHILE 2 NURSES' AIDS WERE REPOSITIONING THE RESIDENT, WHO FELL INTO HER WHEELCHAIR. NO INJURIES WERE SUSTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOYER 600 | MANUFACTURED FLOOR PASSIVE LIFT | FSA | ARJOHUNTLEIGH MAGOG | 9600132.06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |