BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3142282 · Received May 21, 2013

    Report

    Report Number
    9710055-2013-00023
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K954169
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET SAS BELIEVES MOST LIKELY CAUSE OF THIS EVENT WAS THE PRESENCE OF FINGERPRINTS ON THE SURFACE OF 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. ON A SIMILAR CASE, MAQUET 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. 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. EXEMPTION NUMBER: (B)(4) SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    REF NUMBER: 3008355164-2013-00126.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225252 MAQUET SAS FSY MAQUET S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1