BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2545236 · Received March 28, 2012

    Report

    Report Number
    9710055-2012-00006
    Event Type
    Malfunction
    Date Received
    March 28, 2012
    Date of Event
    February 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    MAQUET S.A.
    Product Code
    FTD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL STAFF REPORTED TO A MAQUET FIELD SERVICE TECH (FST) ON SITE THAT THE FASTENING HARDWARE (12 SCREWS) HAD SHEARED OFF. HOWEVER, THE HOSPITAL STAFF DID NOT PROVIDE ANY EXPLANATION AS TO HOW ALL 12 SCREWS/BOLTS FAILED AT THE SAME TIME. THE FST WAS INFORMED THAT ALL OF THE HARDWARE WAS THROWN OUT BY THE HOSPITAL STAFF AND ANY REMNANTS OF THE SCREWS IN THE BOOM WERE DRILLED OUT TO FACILITATE A REPAIR. THE HOSPITAL FAILED TO CAPTURE ANY PHOTOS OF THE BROKEN PARTS BEFORE DISCARDING THEM. THE HANAUPORT SERIES OPERATING MANUAL MENTIONS THAT PENDANT SYSTEMS ARE TO BE SERVICED BY MAQUET OR AN AUTHORIZED CUSTOMER SERVICE ENGINEER ONCE A YEAR. INCLUDED IN THE YEARLY MAINTENANCE PROGRAM ARE SEVERAL MECHANICAL SAFETY VERIFICATIONS. THE HOSPITAL IS THE PRIMARY SERVICE PROVIDER FOR THIS UNIT. IT DID NOT PROVIDE MAQUET ANY SERVICE RECORDS FOR THIS DEVICE. THIS UNIT HAS PRESENTLY BEEN REMOVED FROM SERVICE PENDING THE DELIVERY OF NEW HARDWARE. THIS OCCURRENCE IS THE ONLY ONE REPORTED TO MAQUET, OUT OF (B)(4) UNITS SOLD WORLDWIDE. EXEMPTION# (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AN EQUIPMENT BOOM BROKE AND CAME APART IN OPERATING ROOM 4. NO INJURIES WERE REPORTED. THERE WAS NO PT IN THE ROOM AT THE TIME OF THE INCIDENT. IT HAPPENED AS THE ROOM WAS BEING TURNED OVER. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS FTD MAQUET S.A. HANAUPORT

    Patients

    Seq Age Sex Outcome Treatment
    1