BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPAP AUTO M-SERIES

    MDR report key: 2625856 · Received June 8, 2012

    Report

    Report Number
    2518422-2012-00618
    Event Type
    Other
    Date Received
    June 8, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 11, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K061034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MANUFACTURER AND CONFIRMED IT DID NOT CYCLE TO THE INHALATION PRESSURE. HOWEVER, THE DEVICE DID PROPERLY PROVIDE EXHALATION PRESSURE AS INTENDED. THE DEVICE ERROR LOG INDICATED THIRTY-TWO, OCCLUDED FLOW SENSOR ERROR CODES BEGINNING (B)(6) 2012. DISASSEMBLY OF THE DEVICE REVEALED EVIDENCE OF WATER INGRESS TO THE FLOW SENSOR THAT HAD RESULTED IN ITS CORROSION AND FAILURE. THE MANUFACTURER CONCLUDED THE FAILURE OF THE DEVICE WAS THE RESULT OF WATER INGRESS AND CORROSION TO THE FLOW SENSOR PRINTED CIRCUIT ASSEMBLY (PCA). PATIENT LABELING WARNS THE USER AGAINST MISHANDLING AND WATER INGRESS. THE DEVICE IS INTENDED FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA AND THE SHORT-TERM LOSS OF THERAPY BY ITSELF DOES NOT POSE A SIGNIFICANT HEALTH OR SAFETY RISK. IN ADDITION TO THE OBSTRUCTIVE SLEEP APNEA, THE PATIENT WAS ALSO SUFFERING FROM COPD AND WAS RECEIVING 4L/MIN OF OXYGEN 24-HOURS PER DAY. A REVIEW OF THE DEVICE'S COMPLAINT HISTORY RECORD FROM JANUARY 1, 2006 TO JUNE 6, 2012 INDICATES 1 OTHER SIMILAR INCIDENT ASSOCIATED WITH THIS FAILURE. G5: K050759.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED BY THE (B)(4) THAT A PATIENT ON AN OXYGEN THERAPY WAS HOSPITALIZED FOR 9 DAYS WITH HYPERCAPNIA DUE TO THE BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE NOT CYCLING FROM EXHALATION PRESSURE TO THE INHALATION PRESSURE. THE PATIENT HAS SINCE BEEN DISCHARGED AND HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP AUTO M-SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC. 700M

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization M-SERIES (DC) HEATED HUMIDIFIER: (B)(4),| OXYGEN CONCENTRATOR| (B)(4)| INOGENE ONE