BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1671364 · Received April 22, 2010

    Report

    Report Number
    1671364
    Event Type
    Malfunction
    Date Received
    April 22, 2010
    Date of Event
    April 20, 2010
    Report Date
    April 22, 2010
    Manufacturer
    C&S ELECTRONICS INC
    Product Code
    KTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S FOREARM SUSTAINED 3-4 BURN BLISTERS AFTER UNDERGOING SWEAT CHLORIDE TEST. THIS WAS REPORTED BY CHILD'S MOTHER AFTER THEY RETURNED HOME. NO MEDICAL TREATMENT REQUIRED.====================== HEALTH PROFESSIONAL'S IMPRESSION======================LOW VOLTAGE ON SWEAT TEST APPARATUS LEAD TO HIGH AMPS. THIS WAS DUE TO LOW BATTERY CHARGE. BATTERIES REPLACED. RECOMMENDATION BY HOSPITAL BIOMED IS TO CHANGE BATTERIES EVERY 6 MONTHS.====================== MANUFACTURER RESPONSE FOR SWEAT TEST APPARATUS, (BRAND NOT PROVIDED)======================PEDS PULMONARY CLINIC SPOKE WITH MANUFACTURER. I AM UNAWARE WHAT WAS SAID DURING THE CONVERSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SWEAT TEST APPARATUS KTB C&S ELECTRONICS INC IPS-25A *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO NO OTHER THERAPIES