BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET EQUIPMENT

    MDR report key: 17728412 · Received September 12, 2023

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    Report

    Report Number
    9710055-2023-00677
    Event Type
    Malfunction
    Date Received
    September 12, 2023
    Date of Event
    August 23, 2023
    Report Date
    September 12, 2023
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    UDI-DI
    03700712400972
    PMA / PMN Number
    K070442
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION OF D1 BRAND NAME, D2 PRODUCT CODE, D2 PRODUCT CODE DESCRIPTION, D4 VERSION OR MODEL #, D4 UNIQUE IDENTIFIER (UDI) #, H3A DEVICE EVALUATED BY MFG, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE-EXPLAIN DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS D1 BRAND NAME: MAQUET EQUIPMENT. CORRECTED D1 BRAND NAME: NA. PREVIOUS D2 PRODUCT CODE. : FXR. CORRECTED D2 PRODUCT CODE. : FSY. PREVIOUS D2 PRODUCT CODE DESCRIPTION.: HOLDER, CAMERA, SURGICAL. CORRECTED D2 PRODUCT CODE DESCRIPTION.: LIGHT, SURGICAL, CEILING MOUNTED. PREVIOUS D4 VERSION OR MODEL # : ARD567912921. CORRECTED D4 VERSION OR MODEL # : ARDEQT239006A. PREVIOUS D4 UNIQUE IDENTIFIER (UDI) #: N/A. CORRECTED D4 UNIQUE IDENTIFIER (UDI) #: (B)(4). PREVIOUS H3A DEVICE EVALUATED BY MFG: NO. CORRECTED H3A DEVICE EVALUATED BY MFG: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: NONE. PREVIOUS H3C IF OTHER PROVIDE CODE-EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE-EXPLAIN: NONE. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EQUIPMENT - SINGLE ARM SAHORMS 14. AS IT WAS STATED, THE ARM END CAPS WERE LOOSE DUE TO THE RETAINING LUGS WHICH HAVE BROKEN OFF. THERE WAS NO INJURY REPORTED AND THE CIRCUMSTANCES OF THE ISSUE ARE UNKNOWN. HOWEVER, CONSIDERING THE WORSE CASE SCENARIO, THE BROKEN OFF PARTS COULD FALL OFF INTO THE STERILE FIELD AND THE MISSING PART COULD DETACH FROM THE DEVICE AND FALL OFF INTO THE STERILE FIELD, THEREFORE WE DECIDED TO REPORT THIS ISSUE IN ABUNDANCE OF CAUTION AS IT MIGHT BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL EQUIPMENT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. THERE IS NO INFORMATION IF THE CLAIMED DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. ROOT CAUSE ANALYSIS WAS PERFORMED BY SUBJECT MATTER EXPERT AT MANUFACTURER¿S. THE ANALYSIS IS FOLLOWING: MAQUET DID NOT RECEIVE ENOUGH INFORMATION TO CONDUCT THE TECHNICAL INVESTIGATION. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE AND THEREFORE THE FACTORY INVESTIGATION REPORT CAN NOT BE PERFORMED. IN CASE OF NEW RELEVANT INFORMATION, THE CASE WILL BE RECONSIDERED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1I EVENT SITE TELEPHONE: (B)(6). H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR EQUIPMENT - SINGLE ARM SAHORMS 14. AS IT WAS STATED, THE ARM END CAPS WERE LOOSE DUE TO THE RETAINING LUGS WHICH HAVE BROKEN OFF. THERE WAS NO INJURY REPORTED AND THE CIRCUMSTANCES OF THE ISSUE ARE UNKNOWN. HOWEVER, CONSIDERING THE WORSE CASE SCENARIO THE BROKEN OFF PARTS COULD FALL OFF INTO THE STERILE FIELD, THEREFORE WE DECIDED TO REPORT THIS ISSUE IN ABUNDANCE OF CAUTION AS IT MIGHT BE A SOURCE OF CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145230 MAQUET EQUIPMENT LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDEQT239006A 03700712400972
    2127802 MAQUET EQUIPMENT LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS ARDEQT239006A 03700712400972

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown