BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 8313405 · Received February 6, 2019

    Report

    Report Number
    0003015876-2019-00202
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 16, 2019
    Report Date
    April 1, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00885074269252
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G5 PMA/510(K)# OF THE INITIAL MEDWATCH REPORT INDICATES: BLANK SECTION G5 PMA/510(K)# OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: K102972.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THEIR DEVICE POWERED ITSELF OFF AND THEY ALSO STATED THAT IT DRAINS THE BATTERIES IN THE DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. AFTER COMPLETING OTHER UNRELATED REPAIRS, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THEIR DEVICE POWERED ITSELF OFF AND THEY ALSO STATED THAT IT DRAINS THE BATTERIES IN THE DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102884 LIFEPAK® 12 DEFIBRILLATOR/MONITOR SERIES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 NA 00885074269252

    Patients

    Seq Age Sex Outcome Treatment
    1