BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREEZE / TRANQUILCARE

    MDR report key: 3004128 · Received March 12, 2013

    Report

    Report Number
    1000381138-2013-00002
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 12, 2013
    Manufacturer
    ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MFR (ARJO LTD. MED (B)(4)). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    SHORT CIRCUIT AT POWER PCB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102964 BREEZE / TRANQUILCARE PAC FNM ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB 625304-R

    Patients

    Seq Age Sex Outcome Treatment
    1