BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3812429 · Received May 15, 2014

    Report

    Report Number
    3015876-2014-00542
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO PHYSIO-CONTROL FOR EVALUATION. PHYSIO EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE FLEX CABLE ASSEMBLY WHICH CONNECTS THE USER INTERFACE PCB ASSEMBLY TO THE PCB STACK AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.THE FLEX CABLE ASSEMBLY APPEARED TO BE BENT AND WORN.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL HAS MADE SEVERAL CONTACT ATTEMPTS TO REACH THE CUSTOMER TO DETERMINE THE STATUS OF THE DEVICE EVALUATION BUT THE CUSTOMER HAS BEEN UNAVAILABLE. IT IS UNKNOWN IF THE DEVICE HAS BEEN REPAIRED OR RETURNED TO SERVICE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS NOT POWERING ON WITH EITHER AC OR DC POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291978 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1