BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 3241588 · Received July 22, 2013

    Report

    Report Number
    3015876-2013-00642
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 27, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS LATER CONFIRMED BY THE CUSTOMER THAT THE HARD PADDLES ASSEMBLY THAT WAS BEING USED WITH THE DEVICE WHEN IT FAILED HAD A LOT CODE OF 09-2008 (SEPTEMBER 2008).

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO TWO (2) BENT PINS IN THE CONNECTOR OF THE HARD PADDLES ASSEMBLY. PHYSIO-CONTROL RECOMMENDED REPLACEMENT OF THE STANDARD HARD PADDLES ASSEMBLY AND PROCEEDED WITH TESTING THE UNIT USING A DIFFERENT SET OF HARD PADDLES. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. IT WAS LATER CONFIRMED THAT THE CUSTOMER PURCHASED A REPLACEMENT SET OF HARD PADDLES.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMED, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE LOST THE QUIK-LOOK FUNCTION WHILE USING STANDARD HARD-PADDLES ON A PATIENT. A VISUAL EXAMINATION SHOWED THAT TWO (2) PINS ON THE STANDARD HARD-PADDLE ASSEMBLY WERE BENT AND THEREFORE NOT MAKING THE CONTACT NEEDED FOR PADDLES LEAD TO FUNCTION. NO FURTHER INFORMATION REGARDING THE PATIENT OR EVENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341677 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E 09-2008

    Patients

    Seq Age Sex Outcome Treatment
    1