FDA Adverse Event
Malfunction
Summary report: N
MALIBU
MDR report key: 2007183
·
Received February 15, 2011
Report
- Report Number
- 9611530-2011-00012
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- October 20, 2010
- Report Date
- October 20, 2010
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- ILJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WE ARE REPORTING ACCORDING TO EXEMPTION TO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4), THE LEGAL MFR, ARJO HOSPITAL EQUIPMENT AB IN (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: REPORTED AS UNCOMMANDED MOVEMENT, TESTED AND FOUND ALL FUNCTIONS U/S, REMOVED HANDSET FOUND TUB UP/DOWN OK. REPLACED HANDSET WITH NEW, TESTED ALL FUNCTIONS OK. (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 |