BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2621317 · Received June 6, 2012

    Report

    Report Number
    9710055-2012-00010
    Event Type
    Malfunction
    Date Received
    June 6, 2012
    Report Date
    May 4, 2012
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH (FST) VISITED THE HOSP (B)(6) 2012 TO INVESTIGATE THE ALLEGED INCIDENT. THE FST FOUND THE LIGHT PACKAGED AND PLACED INTO STORAGE. THE FST EXAMINED THE LIGHT AND FOUND NO OBVIOUS ISSUES. THE MAQUET FST WAS INFORMED BY THE HOSPITAL'S CLINICAL ENGINEER (CE) THAT THE CUPOLA DETACHMENT WAS THE RESULT OF A MISSING STOP SEGMENT. THIS SEGMENT IS HELD IN PLACE BY A SAFETY SLEEVE (OR COLLAR). THE HOSPITAL'S CE STATED THAT THEY HAD FOUND THE COLLAR HAD BROKEN AND THIS ALLOWED THE RETAINING SEGMENT TO BE DISLODGED DURING USE. (THE ROOT CAUSE FOR THE BROKEN SLEEVE WAS NOT PROVIDED). THE CE ALSO REPORTED THAT THE HOSP MAINTENANCE DEPT INITIALLY REPAIRED THIS LIGHT AND RETURNED IT TO SERVICE. LATER, THE UNIT WAS TAKEN DOWN AND REPLACED WITH A 3RD PARTY PRODUCT. GIVEN THAT THE LIGHT WAS NOT IN USE WHEN MAQUET ARRIVED AND THAT THE CUSTOMER HAD REPAIRED ALL PREVIOUS DAMAGE, MAQUET IS UNABLE TO PROVIDE A DEFINITIVE ROOT CAUSE AND MUST RELY UPON THE TESTIMONY PROVIDED BY THE CE. MAQUET PROVIDES INSTRUCTIONS AND WARNINGS IN THE USER MANUAL TO CHECK THE SAFETY SLEEVE AND THE PRESENCE OF STOP SEGMENTS BEFORE USE. IT IS BELIEVED THAT HAD THE LIGHT BEEN PROPERLY MAINTAINED, THE REPORTED EVENT WOULD NOT HAVE OCCURRED. NOTE: THE CE COULDN'T STATE WHY THIS INCIDENT WAS NOT REPORTED TO MAQUET AT THE TIME OF THE EVENT. (B)(4). (B)(6) SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. (B)(6) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    MAQUET WAS CONTACTED BY THE HOSPITAL'S CLINICAL ENGINEER AND INFORMED THAT A MAQUET LIGHTHEAD FELL IN THEIR CRITICAL CARE UNIT. THE ENGINEER STATED THIS EVENT TOOK PLACE BETWEEN 18 AND 24 MONTHS PRIOR TO THE NOTIFICATION OF MAQUET. THE ENGINEER STATED THERE WAS NO PT INVOLVEMENT AT THE TIME OF THE EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS FSY MAQUET SAS PRC

    Patients

    Seq Age Sex Outcome Treatment
    1