BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEWLETT PACKARD CO.

    MDR report key: 157999 · Received March 4, 1998

    Report

    Report Number
    157999
    Event Type
    Malfunction
    Date Received
    March 4, 1998
    Date of Event
    February 23, 1998
    Report Date
    March 3, 1998
    Manufacturer
    HEWLETT PACKARD CO./MEDICAL PROPERTY DIVISION
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADULT STAFF MEMEBER (RN) SUFFERED SEIZURE WHILE TAKING CARE OF PT. CODE WAS CALLED. A DEFIBRILATOR (A SECOND ONE) EQUIPED WITH EXTERNAL PACING CAPABILITY WAS TAKEN TO THE CODE. DURING THE RESUSCITATION ATTEMPT, THE MODE (TO MAKE IT EXTERNAL PACING) WAS UNABLE TO BE CHANGED. THIS DID NOT AFFECT PT'S CODE SITUATION; THE DEFIBRILATOR HOUSED IN THAT PT CARE AREA WAS USED AND FUNCTIONED NORMALLY. MFR WAS CALLED TO ASSESS THE DIFFICULTY WITH EXTERNAL PACING. WHEN REVIEWING THE SITUATION, THE RN AND MFR REALIZED THAT SHE HAD NOT FOLLOWED THE PROPER SEQUENCE TO CHANGE THE MODE DURING THE STRESS OF THE CODE SITUATION. THE MFR, HOWEVER, SUGGESTED THAT THE HOSP'S BIOMEDICAL ENGINEERING DEPARTMENT PERFORM A ROUTINE INVESITGATION ON THE DEFIBRILATOR. EQUIPMENT WAS FOUND TO BE OPERATING NORMALLY. IN ADDITION, THE DEFIBRILATOR HAD ROUTINE PREVENTATIVE MAINTENANCE PERFORMED TWO WEEKS PRIOR TO THIS EVENT AND WAS FOUND TO FUNCTION NORMALLY. PLAN FOR CORRECTIVE ACTION: EDUCATIONAL PROGRAMS HAVE BEEN PUT IN PLACE FOR ALL STAFF AND ALL CODE BLUE TEAM MEMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEWLETT PACKARD CO. DEFIBRILATOR, MONITOR/PACER LDD HEWLETT PACKARD CO./MEDICAL PROPERTY DIVISION M1722A *

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR