FDA Adverse Event
Malfunction
Summary report: N
MALIBU
MDR report key: 2007228
·
Received February 18, 2011
Report
- Report Number
- 9611530-2011-00013
- Event Type
- Malfunction
- Date Received
- February 18, 2011
- Date of Event
- February 4, 2011
- Report Date
- February 4, 2011
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- ILJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
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) IN (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 2011-(B)(6): CHAIR KEEPS DROPPING. INVESTIGATED, FOUND FAULTY HANDSET, ALSO DAMAGED HANDSET HOLDER, BOTH UNITS REPLACED, OPERATION CHECKED ON COMPLETION. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MALIBU | BATH, SITZ, POWERED | ILJ | ARJO HOSPITAL EQUIPMENT AB | OTHER |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |