BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 ACCESSORY PACK

    MDR report key: 8237572 · Received January 10, 2019

    Report

    Report Number
    2242352-2019-00047
    Event Type
    Malfunction
    Date Received
    January 10, 2019
    Date of Event
    December 14, 2018
    Report Date
    January 10, 2019
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K041981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CHANGED EVENT SITE EMAIL FROM (B)(6). CHANGED PMA/510(K)# K091733 TO K041981, CHANGED DEVICE CODES FROM "INFLATION ISSUE" TO "IMPROPER FLOW OR INFUSION." INTERNAL COMPLAINT # TRACKWISE # (B)(4). AUTONUMBER # (B)(4). A LOT NUMBER WAS NOT PROVIDED. A SHIP HISTORY REVIEW WAS PERFORMED. THERE WERE NO VH-2004-VASOVIEW 6 ACCESSORY PACK LOTS SHIPPED TO THE ACCOUNT ONE YEAR PRIOR TO THE AWARE DATE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO BTT PORT DID NOT HOLD INSUFFLATION. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO BTT PORT DID NOT HOLD INSUFFLATION. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26161 VASOVIEW 6 ACCESSORY PACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV

    Patients

    Seq Age Sex Outcome Treatment
    1