BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO M-SERIES

    MDR report key: 2844270 · Received November 8, 2012

    Report

    Report Number
    2518422-2012-02224
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 9, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K072996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT'S LABELING PROVIDES USER CARE AND HANDLING INSTRUCTIONS TO PREVENT WATER INGRESS FROM OCCURRING OR AFFECTING THE OPERATION OF THE DEVICE. THE MFR CONCLUDES THE PRODUCT FAILURE WAS CAUSED BY THE USER MISHANDLING/ABUSE. THE MFR CONCLUDES THAT NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) ALLEGED THAT A THERMAL EVENT RESULTED IN A VOID IN THE TOP ENCLOSURE OF A HEATED HUMIDIFIER. UPON MFR'S RECEIPT, THE VOID ASSOCIATED WITH THE THERMAL EVENT WAS FOUND TO BE ON CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE (CPAP) AND NOT THE HUMIDIFIER. THERE WAS NO REPORT OF HARM OR INJURY. THE MFR DETERMINED THERE WERE SIGNS OF WATER INGRESS TO THE ELECTRODE COMPONENTS INSIDE THE CPAP, LEADING TO A SHORT CIRCUIT AND SUBSEQUENT THERMAL DAMAGE AND COMPROMISE OF THE TOP ENCLOSURE. THERE WAS NO EVIDENCE OF DAMAGE TO THE ASSOCIATED HUMIDIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REMSTAR PRO M-SERIES CONTINUOUS POSITIVE AIRWAY PRESSURE BZD RESPIRONICS, INC. 400M

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR (B)(4)| M-SERIES (DC) HEATED HUMIDIFIER: 1051158,