BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMIDIFIER 350 CC BUBBLE HUMIDIFIER

    MDR report key: 2894398 · Received December 27, 2012

    Report

    Report Number
    2921601-2012-00013
    Event Type
    Other
    Date Received
    December 27, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 26, 2012
    Manufacturer
    SALTER LABS
    Product Code
    CAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012 SALTER LABS CUSTOMER SERVICE RECEIVED A COMPLAINT REGARDING BUBBLE HUMIDIFIER BOTTLE SPLITTING. REPORTEDLY, THE CUSTOMER HAD TO REPLACE AT LEAST ONE HUMIDIFIER BOTTLE BECAUSE HIS WIFE (PATIENT) COMPLAINED THAT SHE FELT SHE WASN'T GETTING ENOUGH OXYGEN. IT IS IMPORTANT TO NOTE THAT THE PRODUCT IN QUESTION IS NOT AVAILABLE FOR RETURN TO SALTER LABS FOR EVALUATION. WITHOUT REVIEWING THE HUMIDIFIER BOTTLE(S), IT IS IMPOSSIBLE TO CONFIRM THE FAILURE AND/OR DETERMINE THE ROOT CAUSE OF THE FAILURE. THE NATURE OF THE MEDICAL INTERVENTION WAS HUMIDIFIER REPLACEMENT. ADDITIONALLY IT'S IMPORTANT TO NOTE THAT SPECIFICS ARE UNKNOWN (SUCH AS PATIENT OXYGEN SATURATION LEVELS AND LOT NUMBER INFORMATION FOR PRODUCT IN QUESTION). NO OTHER HEALTH EFFECTS REPORTED. THIS IS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDIFIER 350 CC BUBBLE HUMIDIFIER BUBBLE HUMIDIFIER CAF SALTER LABS 7600 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other