BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3572301 · Received January 13, 2014

    Report

    Report Number
    3015876-2014-00032
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 16, 2013
    Report Date
    December 16, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: THE CUSTOMER, A BIOMED, CONTACTED PHYSIO-CONTROL TO REPORT THAT THE QUIK-COMBO THERAPY CABLE THAT WAS BEING USED IN CONJUNCTION WITH THEIR DEVICE WAS NOT WORKING PROPERLY. FURTHER DETAILS WERE NOT PROVIDED REGARDING THE EXACT ISSUE BEING EXPERIENCED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE WAS NOT WORKING AND THAT A NEW THERAPY CONNECTOR ASSEMBLY WAS NEEDED TO RESOLVE THE REPORTED ISSUE FOR THE UNIT. FURTHER DETAILS WERE NOT PROVIDED REGARDING THE EXACT ISSUE BEING EXPERIENCED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. CATALOG NUMBER OF THE INITIAL MEDWATCH REPORT INDICATES: 3202459. CATALOG NUMBER OF THE INITIAL MEDWATCH REPORT SHOULD INDICATE: 3202488. THE INITIAL MEDWATCH REPORT INDICATES: PHYSIO-CONTROL ASSISTED THE CUSTOMER WITH PURCHASING A REPLACEMENT QUIK-COMBO THERAPY CABLE. NEITHER THE CABLE, OR THE DEVICE, HAVE BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: PHYSIO-CONTROL ASSISTED THE CUSTOMER WITH PURCHASING A REPLACEMENT THERAPY CONNECTOR ASSEMBLY. AFTER MULTIPLE ATTEMPTS, PHYSIO-CONTROL HAS BEEN UNABLE TO CONTACT THE CUSTOMER FOR MORE INFORMATION REGARDING THE REPORTED ISSUE. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL ASSISTED THE CUSTOMER WITH PURCHASING A REPLACEMENT QUIK-COMBO THERAPY CABLE. NEITHER THE CABLE, OR THE DEVICE, HAVE 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, A BIOMED, CONTACTED PHYSIO-CONTROL TO REPORT THAT THE QUIK-COMBO THERAPY CABLE THAT WAS BEING USED IN CONJUNCTION WITH THEIR DEVICE WAS NOT WORKING PROPERLY. FURTHER DETAILS WERE NOT PROVIDED REGARDING THE EXACT ISSUE BEING EXPERIENCED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24016 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1