BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3841350 · Received May 30, 2014

    Report

    Report Number
    3015876-2014-00601
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND OBSERVED THAT IT WOULD NOT POWER ON DUE TO DAMAGE AND INCORRECT REASSEMBLY CAUSED BY THE BIOMEDICAL ENGINEER DURING HIS ATTEMPT TO REPLACE THE THERAPY CONNECTOR ASSEMBLY. PHYSIO-CONTROL THEN MADE THE NECESSARY REPAIRS TO THE DEVICE. ONCE THE UNIT WAS REPAIRED AND ABLE TO POWER ON AGAIN, PHYSIO WAS ABLE TO CONFIRM THAT THE NEW THERAPY CONNECTOR ASSEMBLY INSTALLED BY THE BIOMEDICAL ENGINEER HAD RESOLVED THE ORIGINAL REPORTED ISSUE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER, A BIOMEDICAL ENGINEER, EXAMINED THE DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE OF THE DEVICE FAILING TO CHARGE AND PROVIDE DEFIBRILLATION ENERGY. DURING THE BIOMED'S TESTING, HOWEVER, HE DID OBSERVED THAT WHEN HE PUT MOVED THE QUIK-COMBO THERAPY CABLE NEAR THE THERAPY CONNECTOR ASSEMBLY THAT PADDLES LEAD ECG WOULD NOT LONGER SHOW THE SIMULATED RHYTHM (FLAT-LINE). THE BIOMEDICAL ENGINEER THEN REPLACED THE THERAPY CONNECTOR ASSEMBLY BUT WAS UNABLE TO FURTHER TEST THE DEVICE TO CONFIRM THAT IT HAD RESOLVED THE ISSUE. THE DEVICE HAS SINCE BEEN RETURNED TO PHYSIO-CONTROL FOR FURTHER EVALUATION. 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.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMEDICAL ENGINEER, CONTACTED PHYSIO-CONTROL TO REPORT THAT DURING A RECENT PATIENT EVENT THEIR DEVICE WOULD NOT CHARGE AND DEFIBRILLATE THE PATIENT. MEDICAL PERSONNEL WERE ATTEMPTING TO CARDIOVERT THE PATIENT WHEN THE ISSUE OCCURRED. A BACKUP DEVICE WAS AVAILABLE AND USED TO SUCCESSFULLY CARDIOVERT THE PATIENT. IT TOOK APPROXIMATELY TWO (2) MINUTES TO OBTAIN AND USE THE BACKUP DEVICE. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319480 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1