BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LDP UNIT

    MDR report key: 33103 · Received May 22, 1996

    Report

    Report Number
    MW1009139
    Event Type
    Injury
    Date Received
    May 22, 1996
    Date of Event
    February 17, 1996
    Report Date
    May 3, 1996
    Manufacturer
    MATRIX MEDICAL, INC.
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS MAINTAINED ACCORDING TO INSTRUCTIONS FROM THE CO. THE UNIT WAS NEVER USED ON A PT FOR DEFIBRILLATION; OCCASIONALLY IT HAD BEEN USED FOR BEDSIDE CARDIAC RHYTHM MONITORING OR FOR INSTRUCTION PURPOSES DURING PRACTIVE "CODE BLUE" SESSIONS WITH STAFF. THE UNIT WAS NEVER DROPPED OR DAMAGED IN ANY WAY. IN 1993 OR 1994 THE CO ISSUED A RECALL FOR THIS PARTICULAR UNIT. THEY SENT A TECH TO THE OFFICE TO REPAIR THE UNIT. RPTR WAS PRESENT AT THE TIME OF THE REPAIR AND SAW THAT THE TECHN REPLACED A SMALL DIODE? CAPACITOR? INSIDE THE UNIT. RPTR WAS THEN ASSURED THAT THE REPAIR WAS COMPLETE, AND THAT THE UNIT WAS RELIABLE. (RPTR HAD HAD NO PROBLEMS WITH THE UNIT BEFORE THE RECALL). OFFICE NURSE WAS DOING THE MONTHLY CHECK ON THE UNIT, CHARGING IT UP THEN DISCHARGING THE CURRENT THRU THE DEFIBRILLATOR PADDLES ONTO THE GROUNDED TERMINALS. AS HE DID THIS, THERE WAS AN EXPLOSION, WHICH BLEW OUT THE BOTTOM OF THE DEFIBRILLATOR CASE. HE WAS NOT INJURED. THIS OCCURRED ON 2/17/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LDP UNIT DEFIBRILLATOR LDD MATRIX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening