BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK CR® PLUS DEFIBRILLATOR

    MDR report key: 7848969 · Received September 5, 2018

    Report

    Report Number
    0003015876-2018-01467
    Event Type
    Death
    Date Received
    September 5, 2018
    Date of Event
    July 30, 2018
    Report Date
    December 3, 2019
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE CHARGE-PAK FLEX ASSEMBLY HAVING AN ON/OFF SWITCH THAT DOES NOT MAKE CONTACT. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Additional Manufacturer Narrative · 0

    OUTCOMES ATTRIBUTED TO THE AE OF THE INITIAL MEDWATCH REPORT WAS BLANK. OUTCOMES ATTRIBUTED TO THE AE OF THE INITIAL MEDWATCH REPORT SHOULD BE "DEATH".

    Additional Manufacturer Narrative · 0

    DEATH DATE OF THE INITIAL MEDWATCH REPORT WAS BLANK. DEATH DATE OF THE INITIAL MEDWATCH REPORT SHOULD BE "(B)(6) 2018".

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THIS DEVICE WAS USED DURING A PATIENT EVENT AND MAY NOT HAVE TURNED ON WHEN THEY OPENED THE LID. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT HAVE BEEN AVAILABLE, IF IT WAS NEEDED. THE PATIENT INVOLVED IN THE EVENT, A 57 YEAR OLD FEMALE, IS DECEASED. THE CUSTOMER WASN'T ABLE TO CONFIRM WHETHER THE USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE OUTCOME OF THE PATIENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THIS DEVICE WAS USED DURING A PATIENT EVENT AND MAY NOT HAVE TURNED ON WHEN THEY OPENED THE LID. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT HAVE BEEN AVAILABLE, IF IT WAS NEEDED. THE PATIENT INVOLVED IN THE EVENT, A 57 YEAR OLD FEMALE, IS DECEASED. THE CUSTOMER WASN'T ABLE TO CONFIRM WHETHER THE USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE OUTCOME OF THE PATIENT.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THIS DEVICE WAS USED DURING A PATIENT EVENT AND MAY NOT HAVE TURNED ON WHEN THEY OPENED THE LID. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT HAVE BEEN AVAILABLE, IF IT WAS NEEDED. THE PATIENT INVOLVED IN THE EVENT, A 57 YEAR OLD FEMALE, IS DECEASED. THE CUSTOMER WASN'T ABLE TO CONFIRM WHETHER THE USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE OUTCOME OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED PATIENT EVENT AND DETERMINED THAT IT IS UNKNOWN WHETHER THE USAGE OF THE DEVICE CONTRIBUTED TO THE OUTCOME OF THE PATIENT. THIS IS DUE TO THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER AND NOT HAVING THE ELECTRONIC DEVICE FILES FROM THE EVENT FOR REVIEW. 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 THIS DEVICE WAS USED DURING A PATIENT EVENT AND MAY NOT HAVE TURNED ON WHEN THEY OPENED THE LID. AS A RESULT, DEFIBRILLATION THERAPY WOULD NOT HAVE BEEN AVAILABLE, IF IT WAS NEEDED. THE PATIENT INVOLVED IN THE EVENT, A (B)(6) YEAR OLD FEMALE, IS DECEASED. THE CUSTOMER WASN'T ABLE TO CONFIRM WHETHER THE USE OF THE DEVICE CAUSED OR CONTRIBUTED TO THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686311 LIFEPAK CR® PLUS DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death