BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 2486342 · Received March 9, 2012

    Report

    Report Number
    3015876-2012-00169
    Event Type
    Malfunction
    Date Received
    March 9, 2012
    Date of Event
    October 11, 2011
    Report Date
    October 11, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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

    CORRECTION INFORMATION: THE INITIAL MEDWATCH REPORT STATED THE CATALOG NUMBER AS 3202487 AND THE SERIAL NUMBER AS (B)(4). INITIAL MEDWATCH REPORT SHOULD HAVE THE CATALOG NUMBER AS 3202488 AND THE SERIAL NUMBER AS (B)(4). THE INITIAL MEDWATCH REPORT READS: (B)(4) 2006 OF THE INITIAL MEDWATCH REPORT SHOULD READ: (B)(4) 2004. FOLLOW UP INFORMATION: PHYSIO-CONTROL FURTHER EVALUATED THE DEVICE AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A MISSING BOARDSTACK CONNECTOR, WHICH CONNECTS MULTIPLE PCB ASSEMBLIES. THE DEVICE WAS PREVIOUSLY REPAIRED BY PHYSIO-CONTROL FOR AN UNRELATED FAILURE AND WAS REASSEMBLED INCORRECTLY, WITHOUT THE BOARDSTACK CONNECTOR. THE DEVICE WILL BE REPAIRED AND PLACED BACK INTO SERVICE FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT RECOGNIZE THE THERAPY CABLE ASSEMBLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1