BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR2 DEFIBRILLATOR

    MDR report key: 10373327 · Received August 6, 2020

    Report

    Report Number
    0003015876-2020-01003
    Event Type
    Malfunction
    Date Received
    August 6, 2020
    Date of Event
    May 19, 2020
    Report Date
    February 8, 2021
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873824122
    PMA / PMN Number
    P170018
    Removal / Correction Number
    3015876-01/14/2021-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN ENGINEERING INVESTIGATION HAS DETERMINED THAT DUE TO THE DESIGN OF THE LCPR2 LID SWITCH, ABSENCE OF THE LID MAGNET ALLOWS CURRENT TO FLOW FROM THE BATTERY, EVEN WHEN THE DEVICE IS IN STANDBY MODE. THIS WILL REDUCE THE LIFE OF THE BATTERY. THEREFORE, THE REPORTED ISSUE, THE LOSS OF LID/LID MAGNET, IS ASSOCIATED WITH TWO HAZARDOUS SITUATIONS: OPENING THE LID DOES NOT TURN ON THE DEVICE, AND, HIGHER THAN INTENDED CURRENT DRAW WHILE THE DEVICE IS IN STANDBY MODE RESULTS IN A PREMATURELY DEPLETED THE BATTERY. REPLACEMENT OF THE DEVICE LID SO THAT THE MAGNET IS PRESENT IN THE DEVICE ALLOWS THE LID SWITCH TO FUNCTION AS DESIGNED; TURNING ON/OFF THE DEVICE WHEN THE LID IS OPENED AND PREVENTING CURRENT DRAW WHEN THE DEVICE LID IS CLOSED. THE LPCR2 OPERATING INSTRUCTIONS HAS BEEN UPDATED TO INCLUDE ADDITIONAL TROUBLESHOOTING TIPS TO DIRECT THE CUSTOMER TO ACT WHEN DEVICE BEHAVIOR INDICATES THE LID MAGNET MAY BE MISSING. A NEW WARNING INFORMS THE CUSTOMER OF THE RISK ASSOCIATED WITH A MISSING MAGNET.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S LID MAGNET IS MISSING FROM THE LID. WITHOUT THE MAGNET, THE DEVICE WILL NOT POWER ON AUTOMATICALLY WHEN THE LID IS OPENED. THIS MAY RESULT IN DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S LID AND DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS AN OUT-OF-SPEC DIMENSIONS FOR THE LID ASSEMBLY, WHICH RESULTED IN THE MISSING MAGNET. THE CUSTOMER HAS BEEN PROVIDED WITH A REPLACEMENT LID.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE'S LID MAGNET IS MISSING FROM THE LID. WITHOUT THE MAGNET, THE DEVICE WILL NOT POWER ON AUTOMATICALLY WHEN THE LID IS OPENED. THIS MAY RESULT IN DEFIBRILLATION THERAPY BEING DELAYED OR UNAVAILABLE, IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837261 LIFEPAK CR2 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 CR2 00883873824122

    Patients

    Seq Age Sex Outcome Treatment
    1