BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART SLA BATTERY

    MDR report key: 3031278 · Received March 5, 2013

    Report

    Report Number
    1218950-2013-00770
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE BATTERY FAILED TO HOLD A CHARGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. 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 BATTERY FAILED TO HOLD A CHARGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94748 HEARTSTART SLA BATTERY DQA, MKJ, LDD, DRO DQA PHILIPS MEDICAL SYSTEMS M3516A

    Patients

    Seq Age Sex Outcome Treatment
    1