BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLED

    MDR report key: 5726131 · Received June 15, 2016

    Report

    Report Number
    9710055-2016-00040
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    April 29, 2016
    Report Date
    October 11, 2016
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K070442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN EVALUATED THE POWER LED LIGHT AND DID NOT FIND ANY FAILURES. THE SURGICAL LIGHT SYSTEM WAS FUNCTIONING ACCORDING TO SPECIFICATIONS. MAQUET DETERMINED THAT THE ASSEMBLY THAT FAILED BELONGS TO A NON-MAQUET DEVICE THAT WAS COMBINED TO THE POWERLED LIGHT. MAQUET DETERMINED THAT THE ASSEMBLY THAT FAILED BELONGS TO A (B)(6) DEVICE THAT WAS COMBINED TO THE POWERLED LIGHT : MODEL PORTEGRA OT25BO5 SN: (B)(4) AND ITS SPRING ARM OT50U010-MQ SN:(B)(4). MAQUET SAS FORWARDED THE COMPLAINT TO (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET WAS NOT ABLE TO EVALUATE THE ASSEMBLY THAT FAILED AS IT WAS DISCARDED BY THE CUSTOMER. MAQUET DETERMINED THAT THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS A C-CLIP - LOCATED AT THE JUNCTION BETWEEN THE LIGHT AND THE X-RAY PROTECTION SYSTEM - THAT WAS INCORRECTLY SET BY THE USER FACILITY. THE POWER LED SERIES INSTALLATION MANUAL INCLUDES INSTRUCTIONS RELATED TO THE POSITIONING OF THE C-CLIP. ADDITIONALLY, THE DEVICE WAS DIRECTLY INVOLVED WITH THE REPORTED INCIDENT AND WAS BEING USED FOR TREATMENT OF PATIENT WHEN THE EVENT OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A X-RAY PROTECTION SHIELD AND ITS SPRING ARM DETACHED AND FELL OFF OF THE CEILING SUSPENSION WHILE DOCTOR ADJUSTED IT DURING A SURGICAL INTERVENTION. IT WAS REPORTED THAT THE DOCTOR'S HAND WAS INJURED. THERE WERE NO INJURIES TO PATIENT. THIS EVENT IS BEING REPORTED PER 21CFR PART 803 BECAUSE THE MAQUET DEVICE CONTRIBUTED TO THE REPORTED EVENT, AS IT WAS COMBINED TO THE FOREIGN DEVICE THAT FAILED. FACTORY REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381505 POWERLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS PWD50+SFHORXOK3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other