BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROLITE

    MDR report key: 112222 · Received August 5, 1997

    Report

    Report Number
    1931654-1997-00002
    Event Type
    Malfunction
    Date Received
    August 5, 1997
    Date of Event
    July 4, 1997
    Report Date
    July 21, 1997
    Manufacturer
    MEDICAL INDUSTRIES AMERICA, INC.
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DIST PRO-TECH, THE PT'S SPOUSE NOTIFIED PRO-TECH, THE PT'S SHEETS AND BEDSPREAD BURNT WHEN THE DEVICE'S POWER CORD ARCED. FURTHER CONVERSATION WITH PT'S SPOUSE REVEALED THE FOLLOWING INFO: 1. THE PT HAD JUST FINISHED A TREATMENT AND WAS NOT TAKING A TREATMENT AT THE TIME OF THE EVENT. 2. AT NIGHT, THE DEVICE SITS ON TOP OF A DOUBLED OVER BEDSPREAD ON THE PT'S BED. 3. THE PT ALSO USES THIS SAME DEVICE FOR CAR TRIPS. THE PT WOKE THE SPOUSE WHEN THE PT SMELLED SOMETHING BURNING. BY THE TIME THEY LOCATED THE SOURCE OF THE SMELL, A HOLE HAD BURNT THROUGH BOTH LAYERS OF THE BEDSPREAD, THE SHEETS AND THE MATTRESS. PRIOR TO RETURNING THE DEVICE, THE CUSTOMER DUPLICATED THE ARCING BY MOVING THE DC JACK'S PIN TO MAKE A DIRECT SHORT WITH THE JACK'S OUTER RING. THE CUSTOMER NOTED THE CENTER PIN WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROLITE PORTABLE COMPRESSOR NEBULIZER CAF MEDICAL INDUSTRIES AMERICA, INC. 4003 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN