BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 4111211 · Received September 23, 2014

    Report

    Report Number
    3015876-2014-01113
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 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

    (B)(4): 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONFIRMED WITH THE CUSTOMER THAT THE DEVICE WILL NOT BE REPAIRED AND WILL BE USED AS A TRADE IN FOR A REPLACEMENT DEVICE. THE DEVICE HAS NOT BEEN EVALUATED BY PHYSIO-CONTROL. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS INTERMITTENTLY LOCKING UP. THERE WAS NO REPORT OF ANY PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590525 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1