BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 9239196 · Received October 25, 2019

    Report

    Report Number
    0003015876-2019-01749
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 1, 2019
    Report Date
    March 19, 2020
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE STRYKER REPRESENTATIVE PERFORMED UNRELATED REPAIRS AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER. A CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    SECTION G5 PMA/510(K)# OF THE INITIAL MEDWATCH REPORT WAS 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 THAT THEIR DEVICE HAD PROMPTED "ABNORMAL ENERGY DELIVERY" AFTER PROVIDING A SHOCK. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD PROMPTED "ABNORMAL ENERGY DELIVERY" AFTER PROVIDING A SHOCK. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PERFORMED AN INITIAL EVALUATION OF THE CUSTOMER'S DEVICE AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD PROMPTED "ABNORMAL ENERGY DELIVERY" AFTER PROVIDING A SHOCK. IN THIS STATE, WRONG DEFIBRILLATION THERAPY MAY BE DELIVERED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033390 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 NA

    Patients

    Seq Age Sex Outcome Treatment
    1