BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK® 1000 DEFIBRILLATOR

    MDR report key: 8544362 · Received April 24, 2019

    Report

    Report Number
    0003015876-2019-00701
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 29, 2019
    Report Date
    December 11, 2019
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873815458
    PMA / PMN Number
    K122600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MEDWATCH REPORT INDICATES: PMA/510K NUMBER: BLANK. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: PMA/510K NUMBER: K122600.

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND CONFIRMED THAT IT WAS NOT CONFIGURED FOR ECG MONITORING. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE DOES NOT RECOGNIZE WHEN THE ECG CABLE IS CONNECTED AND PROMPTS THE USER TO "CONNECT ELECTRODES AND CABLE." AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT WAS NEEDED. 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 DOES NOT RECOGNIZE WHEN THE ECG CABLE IS CONNECTED AND PROMPTS THE USER TO "CONNECT ELECTRODES AND CABLE." AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT WAS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE 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 DOES NOT RECOGNIZE WHEN THE ECG CABLE IS CONNECTED AND PROMPTS THE USER TO "CONNECT ELECTRODES AND CABLE." AS A RESULT, DEFIBRILLATION THERAPY MAY BE UNAVAILABLE, IF IT WAS NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337420 LIFEPAK® 1000 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 1000 00883873815458

    Patients

    Seq Age Sex Outcome Treatment
    1