BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFE-PAK 9-P

    MDR report key: 227721 · Received June 8, 1999

    Report

    Report Number
    MW1016541
    Event Type
    Injury
    Date Received
    June 8, 1999
    Date of Event
    May 27, 1999
    Report Date
    May 27, 1999
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO CARDIOVERT A-FIB. PT WAS MONITORED USING PHYSIO CONTROL LIFE PAK 9-P/QUICK COMBO PACING/DEFIB/SHOCK ADVISORY ADAPTOR. "SYNCH" MODE IN USE, PT WAS SEDATED WITH BREVITOL 100 MG / ANESTHESIA. CARDIOVERSION WITH SYNCH MARKER ON QRS DONE AT 100 JOULES. RESULTING RHYTHM WAS V-FIB. PT IMMEDIATELY DEFIBRILLATED AT 200 JOULES. CONVERTED TO REGULAR SINUS RHYTHM W/ 1ST DEGREE ATRIOVENTRICULAR BLOCK; PULSE PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE-PAK 9-P MONITOR/DEFIBRILLATOR LDD PHYSIO-CONTROL CORP. LIFE-PAK 9-P *
    2 QUICK COMBO ADAPTOR SHOCK ADVISORY ADAPTOR MKJ PHYSIO-CONTROL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening