BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 7907784 · Received September 25, 2018

    Report

    Report Number
    0003015876-2018-01587
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    September 4, 2018
    Report Date
    December 3, 2018
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873853863
    PMA / PMN Number
    P160026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K)#, OF THE INITIAL MEDWATCH REPORT INDICATED: K130454 PMA/510(K)#, OF THE INITIAL MEDWATCH REPORT SHOULD HAVE INDICATED: P160026 NEW INFORMATION FOR SUPPLEMENTAL MEDWATCH REPORT: PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO-CONTROL THEN REMOVED THE POWER SUPPLY ASSEMBLY FOR FURTHER EXAMINATION WHERE IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS PROCESS RESIDUE ON A FILTER, DESIGNATOR FL10.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHEN THEIR DEVICE IS POWERED ON, IT JUST REBOOTS CONTINUOUSLY. AFTER MULTIPLE ATTEMPTS TO POWER THE DEVICE ON, IT FINALLY DID BOOT-UP BUT HAD A WHITE DISPLAY. A WHITE DISPLAY IS INDICATIVE OF A DEVICE LOCKUP CONDITION. EITHER CONDITION WOULD PREVENT DEFIBRILLATION, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE. 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 WHEN THEIR DEVICE IS POWERED ON, IT JUST REBOOTS CONTINUOUSLY. AFTER MULTIPLE ATTEMPTS TO POWER THE DEVICE ON, IT FINALLY DID BOOT-UP BUT HAD A WHITE DISPLAY. A WHITE DISPLAY IS INDICATIVE OF A DEVICE LOCKUP CONDITION. EITHER CONDITION WOULD PREVENT DEFIBRILLATION, IF IT WERE NECESSARY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745964 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 20E 00883873853863

    Patients

    Seq Age Sex Outcome Treatment
    1