BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2950244 · Received February 5, 2013

    Report

    Report Number
    9710055-2013-00003
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K954169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    SAS CONTACTED THE SUPPLIER OF THE HALOGEN BULBS FOR ASSISTANCE. THE SUPPLIER REPORTED THEY TEST 100% OF THE BULBS IN A VACUUM OVEN IN ORDER TO REDUCE RISKS OF BURSTING. MAQUET SAS HAS DETERMINED THAT THE MOST LIKELY CAUSE OF THIS EVENT WAS THE PRESENCE OF FINGERPRINTS AT THE BULB. THE DEPOSIT OF GREASE LEFT ON THE BULB BY A FINGERPRINT WEAKENS THE BULB'S GLASS DURING USE AND CAN LEAD TO THE TYPE OF FAILURE REPORTED. THE PRESENCE OF FINGERPRINTS COULD NOT BE CONFIRMED IN THIS CASE DUE TO THE CONDITION OF THE REPORTED ITEM. THE BLUE 30/80 SERIES OPERATING MANUAL INCLUDES THE FOLLOWING INSTRUCTION FOR USERS: 4.1 REPLACING THE LIGHT BULB ATTENTION: (...) DO NOT TOUCH THE GLASS BODY OF THE HALOGEN BULB WITH BARE FINGERS. (B)(4). MAQUET SAS PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT DURING A COLONOSCOPY THE LIGHT BULB EXPLODED INSIDE THE EXAMINATION CUPOLA. THE EXPLODING BULB CREATED A 2 MM HOLE (APPROXIMATELY) IN THE LIGHT HEAD AND SOME GLASS PIECES FELL TO THE FLOOR. AT THE TIME OF THE EVENT, THE LIGHT HAD BEEN POSITIONED AT TABLE LEVEL TO ILLUMINATE THE EXAMINATION AREA AND NO ONE WAS UNDERNEATH THE DEVICE. NO INJURIES WERE REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47704 MAQUET SAS FSY MAQUET SAS HANAULUX BLUE 30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI