BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMATIC 5001

    MDR report key: 8954757 · Received September 3, 2019

    Report

    Report Number
    9710055-2019-00268
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 28, 2019
    Report Date
    February 6, 2020
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- PRISMATIC. AS IT WAS STATED, DURING INTERVENTION TWO SCREWS OF SUSPENSION TUBE FELL OFF TOGETHER WITH THEIR CABLE CLAMP. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MIGHT BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. THE PROVIDED INFORMATION INDICATED THAT THE DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. DURING THE INVESTIGATION IT WAS FOUND THAT IT IS CONSIDERED AS SINGLE AND ISOLATED EVENT. IT IS FOUND BY SUBJECT MATTER EXPERTS AT THE MANUFACTURER THAT ONLY REPEATED OR VIOLENT IMPACT APPLIED TO THE COVER LOCATION CAN DETACH IT TOGETHER WITH THE CABLE CLAMP, AND THAT THIS CANNOT HAPPEN IN NORMAL CONDITIONS OF USE. THIS WAS CONFIRMED BY SERVICE TECHNICIAN WHO REPAIRED THE DEVICE, AS HE STATED THAT COVER BROKE DUE TO AN IMPACT WITH THE SPRING ARM. WE BELIEVE THAT REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: 243479.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Additional Manufacturer Narrative · 1

    THE ISSUE IS BEING INVESTIGATED BY MANUFACTURING SITE. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER

    Additional Manufacturer Narrative · 1

    THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

    Description of Event or Problem · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2019 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- PRISMATIC. AS IT WAS STATED, DURING INTERVENTION TWO SCREWS OF SUSPENSION TUBE FELL OFF TOGETHER WITH THEIR CABLE CLAMP. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MIGHT BE A SOURCE OF CONTAMINATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751045 PRISMATIC 5001 LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS

    Patients

    Seq Age Sex Outcome Treatment
    1