BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTASCAN

    MDR report key: 2498538 · Received November 17, 2011

    Report

    Report Number
    3006177869-2011-00001
    Event Type
    Malfunction
    Date Received
    November 17, 2011
    Date of Event
    March 18, 2010
    Report Date
    November 3, 2011
    Manufacturer
    MEDIWATCH UK LTD
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PORTASCAN ULTRASOUND BLADDER SCANNER AND BATTERY PACK, WITH THIS PROBLEM, WAS SOLD ONLY IN (B)(6), NOT IN THE USA, BETWEEN 2001 AND 2007. THE PRODUCT AS LATER RE-DESIGNED IN 2007 AND GAINED 510K (K033906) AND SOLD IN THE (B)(6) AND THE USA AS PORTASCAN+. THIS NEWER UNIT HAD A BATTERY PACK USING THE SAME CASE BUT MODIFIED WITH A KEY WAY, SO THE OLDER BATTERY PACK WOULD NOT FIT THE NEWER VERSION OF PORTASCAN+. THE BATTERY PACK USED WITHIN THE NEWER PORTASCAN+, AS SOLD IN THE USA, USED DIFFERENT ELECTRONICS AND A PCB THERMAL CUTOUT HAD BEEN ADDED FOR EXTRA OVER HEATING PROTECTION.

    Description of Event or Problem · 1

    BATTERY PACK OVERHEATED WHEN ON CHARGE. CUSTOMER HAD REMOVED THE BATTERY PACK FROM THE DEVICE TO CHARGE THE BATTERY PACK BUT HAD USED THE WRONG CHARGER WITH A HIGHER OUTPUT VOLTAGE. THE EFFECT OF THE FAILURE WAS TO CAUSE BURNING AROUND THE CONTACT AREA WITH SLIGHT DISTORTION IN THE BATTERY PACK CASE. NO FURTHER INCIDENTS HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORTASCAN BLADDER SCANNER ITX MEDIWATCH UK LTD PA00145

    Patients

    Seq Age Sex Outcome Treatment
    1