BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK CR® PLUS DEFIBRILLATOR

    MDR report key: 12573613 · Received October 4, 2021

    Report

    Report Number
    0003015876-2021-01902
    Event Type
    Death
    Date Received
    October 4, 2021
    Date of Event
    August 31, 2021
    Report Date
    January 20, 2023
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873820551
    PMA / PMN Number
    K033275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO THE DEVICE'S DIGITAL PCB ASSEMBLY. THE CUSTOMER HAS BEEN PROVIDED WITH A REPLACEMENT DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE FAILED TO POWER ON AFTER THE USER ACCIDENTALLY PULLED THE LID OFF WHY TRYING TO USE THE DEVICE. THIS ISSUE IS PATIENT RELATED, THE CUSTOMER INDICATED THE DEVICE USE MAY HAVE CONTRIBUTED TO THE PATIENT DEATH.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. THE CUSTOMER PROVIDED PHYSIO-CONTROL WITH THE AVAILABLE PATIENT INFORMATION. PHYSIO-CONTROL PERFORMED AN INITIAL EVALUATION AND VERIFIED THE REPORTED ISSUE. THE DEVICE WILL BE RETURNED FOR FURTHER ANALYSIS AT THE PRODUCT ANALYSIS CENTER. THE CUSTOMER WAS PROVIDED A REPLACEMENT DEVICE. 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 FAILED TO POWER ON AFTER THE USER ACCIDENTALLY PULLED THE LID OFF WHY TRYING TO USE THE DEVICE. THIS ISSUE IS PATIENT RELATED, THE CUSTOMER INDICATED THE DEVICE USE MAY HAVE CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466962 LIFEPAK CR® PLUS DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CRPLUS 00883873820551

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Male Death