BEUDAMED
    FDA Adverse Event Other Summary report: N

    THE SALTER AIRE PLUS COMPRESSOR

    MDR report key: 3185712 · Received June 18, 2013

    Report

    Report Number
    2921601-2013-00005
    Event Type
    Other
    Date Received
    June 18, 2013
    Date of Event
    May 18, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SALTER LABS
    Product Code
    BTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    ON (B)(6) 2013 SALTER LABS RECEIVED A COMPLAINT REGARDING TUBING ATTACHED TO A COMPRESSOR GETTING HOT AND REPORTEDLY BURNING A (B)(6) PT'S FINGERS AND SKIN ON THEIR ABDOMEN. THE PT HAS BEEN USING THE COMPRESSOR SINCE HE WAS (B)(6) WITHOUT ISSUE. THE PT'S MOTHER SAID SHE WENT TO TURN THE COMPRESSOR OFF, IT WAS HOT TO THE TOUCH. THE PT'S MOTHER NOTICED THE MARKINGS ON THE PT'S ABDOMEN. NO MEDICAL INTERVENTION WAS REQUIRED IN THIS INCIDENT. THE COMPRESSOR WAS RECEIVED BY SALTER LABS, BUT THE TUBING IN QUESTION WAS NOT RETURNED. A SIMILAR TUBE IS BEING TESTED WITH THE RETURNED COMPRESSOR. THIS IS AN INTERIM REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277234 THE SALTER AIRE PLUS COMPRESSOR 8350 COMPRESSOR BTI SALTER LABS 8350

    Patients

    Seq Age Sex Outcome Treatment
    1 22 MO Other