FDA Adverse Event
Malfunction
Summary report: N
PARKER BATH
MDR report key: 2862303
·
Received November 29, 2012
Report
- Report Number
- 9611530-2012-00211
- Event Type
- Malfunction
- Date Received
- November 29, 2012
- Date of Event
- November 8, 2012
- Report Date
- November 8, 2012
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- ILJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MFR ARJO (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
PARKER TUB DOOR NOT STAYING IN UP POSITION. NO TEMPERATURE DISPLAY. AN ARJOHUNTLEIGH TECHNICIAN REPLACED DOOR STRUT AND REPLACED BATTERIES FOR TEMPERATURE DISPLAY. CHECKED WATER TEMPERATURE, OK. TIGHTENED DOOR HANDLE. RAN FULL FUNCTION TEST. OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARKER BATH | BATH SYSTEMS | ILJ | ARJO HOSPITAL EQUIPMENT AB | 420.00.01.01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |