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