BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMP MNGMT CONTROL UNIT

    MDR report key: 3741804 · Received April 11, 2014

    Report

    Report Number
    1033422-2014-00009
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Report Date
    March 14, 2014
    Manufacturer
    KIMBERLY-CLARK HEALTH CARE
    Product Code
    JRR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE DEVICE HISTORY RECORD IS PENDING. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE DHR REVIEW, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT. THE DEVICE WAS NOT RETURNED TO KIMBERLY-CLARK FOR ANALYSIS, THEREFORE WE ARE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS REPORTED EVENT. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    KIMBERLY-CLARK RECEIVED A REPORT STATING, ¿THE HOSPITAL OWNED UNIT HAS A MELTED FUSE. THIS WAS DISCOVERED PRIOR TO USE WHEN PLUGGING IN THE UNIT, THEY COULDN'T GET IT TO TURN ON. NOT USED ON ANY PATIENTS.¿ (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224380 TEMP MNGMT CONTROL UNIT PATIENT WARMING SYSTEM MODEL 1000 CONTROL UNIT JRR KIMBERLY-CLARK HEALTH CARE 01000-01R 4168

    Patients

    Seq Age Sex Outcome Treatment
    1