BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KION

    MDR report key: 813216 · Received February 1, 2007

    Report

    Report Number
    8010042-2007-00025
    Event Type
    Injury
    Date Received
    February 1, 2007
    Date of Event
    January 11, 2007
    Report Date
    January 11, 2007
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    BSZ
    PMA / PMN Number
    K024213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE AB. MAQUET CRITICAL CARE AB PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE ANESTHESIA MACHINE WAS TRANSPORTED TO THE BIOMEDICAL ENGINEERING (EBME) DEPARTMENT FOR CHECKS DUE TO PROBLEMS WITH LOW BATTERY IN THE DEVICE. IT WAS LEFT ON CHARGE OVER THE EVENING. IN THE MORNING, THE EBME PERSONNEL NOTICED A BURNING SMELL FROM THE CONCERNED DEVICE WHEN THEY ARRIVED IN THE DEPARTMENT. WHEN THEY ACCESSED THE BATTERY COMPARTMENT THEY WERE EXPOSED TO FUMES FROM THE BATTERIES. TWO OF THE PERSONNEL ATTENDED THE ACCIDENT & EMERGENCY DEPARTMENT OF THE HOSPITAL AND ONE WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION DURING THE DAY DUE TO BREATHING PROBLEMS. THE DEVICE WAS TAKEN OUTSIDE AND THE BATTERIES REMOVED TO A SAFE STORAGE AREA. THE BATTERIES SHOWED EXTREME OVERHEATING DAMAGE AND WERE DISTORTED, THE HEAT ALSO FUSED BOTH TOGETHER. THE BATTERY CONNECTION CABLE AND COVER WERE BOTH DAMAGED AS A CONSEQUENCE OF THE HEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KION BSZ BSZ MAQUET CRITICAL CARE AB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization