FDA Adverse Event
Malfunction
Summary report: N
CHORUS
MDR report key: 1971731
·
Received January 13, 2011
Report
- Report Number
- 9611530-2011-00001
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- December 28, 2010
- Report Date
- December 28, 2010
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT (B)(4), THE LEGAL MFR, ARJO HOSPITAL EQUIPMENT (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 SVC TECH - "CAREGIVER WAS LOWERING PT, WHEN FOOT SLIPPED OFF THE LIFT FOOT PLATFORM. PT WAS THEN LOWERED DOWN THE REST OF THE WAY TO THE FLOOR. LIFT REAR CASTORS WERE LOCKED, LIFT LEGS WERE OPEN." (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CHORUS | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJO HOSPITAL EQUIPMENT AB | KKA5010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |