BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALTER LABS HIGH FLOW HUMIDIFIER, 6-15 LPM

    MDR report key: 2326624 · Received October 10, 2011

    Report

    Report Number
    2921601-2011-00009
    Event Type
    Other
    Date Received
    October 10, 2011
    Report Date
    October 10, 2011
    Manufacturer
    SALTER LABS
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, COMPLAINANT AND CAREGIVER (B)(6) CONTACTED SALTER LABS INFORMING THAT THE LOW INDICATOR LIGHT ON THE OXYGEN CONCENTRATOR HIS WIFE (THE PT) WAS USING WAS ILLUMINATING AND HIS WIFE WAS ALSO STATING SHE WASN'T RECEIVING AIR. THIS HAS HAPPENED SEVERAL TIMES. WHEN THIS HAPPENED, IT TOOK SEVERAL ATTEMPTS TO UNSCREW THE HUMIDIFIER AND RECONNECT IT. (B)(6) CONTACTED HOME CARE PROVIDER (B)(6) TO INFORM THEM OF THE EQUIPMENT CONDITION. COMPANY A REPLACED THE CONCENTRATOR FOR AN UNRELATED CONDITION AND ALSO REPLACED THE HUMIDIFIER. IT IS IMPORTANT TO NOTE THAT WHILE THE HUMIDIFIER IS SALTER PRODUCT, THE CONCENTRATOR IS MANUFACTURED BY ANOTHER COMPANY. ON (B)(4) 2011, A SALTER REP CONTACTED (B)(6) TO FIND OUT THE CONDITION OF THE PT AND TO DETERMINE IF THE HUMIDIFIER IS AVAILABLE FOR RETURN. (B)(6) INDICATED HIS WIFE IS "DOING FINE" AND SAID THE HUMIDIFIER WAS RETURNED TO COMPANY (B)(6). ON (B)(4) 2011, SALTER CONTACTED COMPANY (B)(6) IN AN ATTEMPT TO GET THE HUMIDIFIER RETURNED TO SALTER LABS FOR FAILURE ANALYSIS. IT IS CURRENTLY UNK IF THE DEVICE IS AVAILABLE FOR RETURN. THIS IS AN INTERIM REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALTER LABS HIGH FLOW HUMIDIFIER, 6-15 LPM HIGH FLOW HUMIDIFIER BTT SALTER LABS 7900 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention