BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 2943542 · Received January 9, 2013

    Report

    Report Number
    1218950-2013-00106
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 18, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE DEVICE IS NOT WORKING ON BATTERY POWER DURING CLINICAL USE. THERE WAS NO REPORTED ADVERSE PT IMPACT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE IS NOT WORKING ON BATTERY POWER DURING CLINICAL USE. THERE WAS NO REPORTED ADVERSE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13062 HEARTSTART SLA BATTERY DQA MKJ LDD DRO DQA PHILIPS MEDICAL SYSTEMS M3516A

    Patients

    Seq Age Sex Outcome Treatment
    1