BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MRL- WELCH-ALLYN MRL MONITOR

    MDR report key: 662113 · Received November 21, 2005

    Report

    Report Number
    MW1037556
    Event Type
    Injury
    Date Received
    November 21, 2005
    Date of Event
    November 16, 2005
    Report Date
    November 21, 2005
    Manufacturer
    WELCH-ALLYN
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report

    Narratives

    Description of Event or Problem · 1

    MRL MONITOR/ PACER/ DEFIB FAILED TO PACE PT IN 3RD DEGREE HEART BLOCK. MRL MONITOR SHOWED LD FAULT. PAD PLACEMENT CONFIRMED CONNECTION TO PADS, CONNECTION TO MONITOR EKG PLACEMENT CONFIRMED. PACER STILL DID NOT WORK. LATER STILL DID NOT WORK. LATER, ATTEMPTED TO DEFIB PT. MONITOR CHARGED BUT WOULD NOT DISCHARGE. CONNECTION RE-CHECKED, ALL CONNECTIONS INTACT. RE-ATTEMPTED DEFIB WITH SUCCESS. ALSO TO MONITOR PT ON LEAD I, II, III, BUT NOT ON PAD SETTING. THE COMBI PADS THAT ATTACH TO CHEST WALL ARE JINGLE USE/ DISPOSABLE. THE MRL MONITOR ITSELF IS MULTI-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRL- WELCH-ALLYN MRL MONITOR MRL-WELCH ALLYN PORTABLE, INTENSIVE CARE SYSTEM LDD WELCH-ALLYN PIC 50-PORT 971027E

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening