BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAC-PAC

    MDR report key: 7026701 · Received November 13, 2017

    Report

    Report Number
    3018859-2017-00908
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 11, 2017
    Report Date
    October 16, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    CCX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT VAC PAC DEVICE WAS RETURNED TO NATUS AND EVALUATED. A VISUAL INSPECTION CONFIRMED A 17 MM BY 2 MM DEMARCATION, BUT NOT A HOLE. SUCTION WAS APPLIED TO THIS VAC PAC WITH THE VALVE CAP ON, AND THE VAC PAC REMAINED FIRM AND SUCTIONED. SUCTION WAS APPLIED AGAIN, AND THE PRODUCT SOFTENED AFTER 24 HOURS. THE VAC PAC WAS THEN INFLATED WITH AIR, AND AIR LOSS AT THE VALVE WAS OBSERVED. THE SUSPECTED CAUSE OF THE VAC PAC LEAK IS A WORN OUT INNER VALVE FROM REPEATED USE. THE CUSTOMER WAS PROVIDED INFORMATION FOR STORAGE, REPAIR, TESTING AND REPLACEMENT, AND THE CUSTOMER OPTED TO REPLACE THEIR VAC PAC. USERS ARE INSTRUCTED TO CHECK THE VAC PAC DEVICE BEFORE AND AFTER EACH USE AND NOT TO USE THE DEVICE IF THERE IS KNOWN DAMAGE OR A LEAK. USERS ARE ALSO INSTRUCTED TO REPLACE UNITS OLDER THAN TWO YEARS THAT ARE USED SEVERAL TIMES A WEEK.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY CONTACTED NATUS MEDICAL TO REPORT THAT A PATIENT INCIDENT OCCURRED WITH A VAC PAC, BUT THE CUSTOMER WAS UNABLE TO DETERMINE WHICH VAC PAC WAS INVOLVED WITH THE INCIDENT. THIS REPORT CONCERNS A VAC PAC LOT N102315-02. NO DEATH, SERIOUS INJURY OR PATIENT HARM HAS BEEN REPORTED. NO ENVIRONMENTAL OR SAFETY CONCERNS HAVE ALSO BEEN REPORTED. THE CUSTOMER REPORTED A SLIGHT DELAY IN TREATMENT DESCRIBED BELOW. THE CUSTOMER REPORTED THAT THE VAC PAC DEFLATED DURING A SURGICAL PROCEDURE, IN WHICH THE PATIENT WAS PLACED IN THE LATERAL POSITION (RIGHT SIDE UP). SURGICAL STAFF THEN STOPPED THE PROCEDURE SO THAT THE CIRCULATING NURSE COULD CHECK THE PATIENT'S POSITION AND REINFLATE THE VAC PAC. WHILE CHECKING THE VAC PAC, THE CIRCULATING NURSE NOTICED THAT THE VALVE HAD BEEN CLOSED. NO OTHER OPENINGS COULD BE FOUND ON THE VAC PAC. THE CIRCULATING NURSE THEN OPENED THE VALVE AND CONNECTED THE BAG TO WALL SUCTION. SURGICAL STAFF WAS REPORTED TO HAVE BEEN HOLDING THE PATIENT IN POSITION DURING THIS TIME. LASTLY, THE CUSTOMER REPORTED THAT SURGERY CONTINUED AFTER NO NOTICEABLE PATIENT INJURY WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804228 VAC-PAC VAC-PAC CCX NATUS MEDICAL INCORPORATED 51630 N102315-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other