BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3821298 · Received May 20, 2014

    Report

    Report Number
    3015876-2014-00568
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 29, 2014
    Report Date
    April 29, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS LATER CONFIRMED BY THE BIOMEDICAL ENGINEER AT THE CUSTOMER FACILITY THAT HE REPLACED THE THERAPY CONNECTOR ASSEMBLY TO RESOLVE THE REPORTED ISSUE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS PLACED BACK INTO SERVICE FOR USE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT A PIN HAD BROKEN OFF OF A SET OF EITHER HARD PADDLES OR A THERAPY CABLE AND BECOME LODGED IN THEIR DEVICE'S THERAPY CONNECTOR ASSEMBLY. AS A RESULT, DEFIBRILLATION THERAPY WAS NOT LIKELY AVAILABLE BECAUSE ANOTHER THERAPY CABLE OR HARD PADDLES WOULD NOT PLUG IN TO THE DEVICE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300030 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1