BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP A30, SILVER

    MDR report key: 20300226 · Received September 25, 2024

    Report

    Report Number
    2518422-2024-59509
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    October 17, 2023
    Report Date
    February 10, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959067578
    PMA / PMN Number
    K113053
    Removal / Correction Number
    Z-1814-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON PREVIOUSLY REPORTED, A BIPAP A30-S SILVER VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REPLACEMENT PER FIELD ACTION: C&R 2021-05/06. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, AN ERROR CODE (FAILURE OF THE OUTLET PRESSURE SENSOR) WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE SYSTEM PCA NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. DURING THE EVALUATION OF THE DEVICE AT THIRD-PARTY SERVICE CENTER, A "VENTILATOR INOPERATIVE" CONDITION WAS IDENTIFIED. THE DEVICE'S BOARD WILL BE REPLACED TO ADDRESS THE REPORTED OCCURRENCE OF A VENTILATOR INOPERATIVE ERROR BEING TRIGGERED. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED. PRIOR TO IDENTIFYING THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039, COMPLAINTS ASSOCIATED WITH THE ISSUE DID NOT MEET REQUIREMENTS FOR VIGILANCE REPORTING AS A REPORTABLE INCIDENT. AS PART OF THE HHE PROCESS, A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH THE ISSUE DESCRIBED IN FSN 2023-CC-SRC-039 WAS NECESSARY TO REASSESS REPORTABILITY. UPON THIS FURTHER ASSESSMENT, THESE COMPLAINTS ARE BEING REPORTED. THE BIPAP A30-S (B)(6) IS SUBSTANTIALLY SIMILAR TO THE BIPAP A30 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A30, 510K NUMBER: K113053.

    Additional Manufacturer Narrative · 0

    THE BIPAP A30-S SILVER SERIES MODEL# 1116155 IS SUBSTANTIALLY SIMILAR TO THE BIPAP A30 1111144 AND WILL BE REPORTED IN THE UNITED STATES UNDER BIPAP A30-S SILVER SERIES, 501K NUMBER: K113053..

    Description of Event or Problem · 0

    A BIPAP A30-S SILVER VENTILATOR WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR FOAM REPLACEMENT PER FIELD ACTION: C&R 2021-05/06. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, AN ERROR CODE (FAILURE OF THE OUTLET PRESSURE SENSOR) WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THE SYSTEM PCA NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084905 BIPAP A30, SILVER VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 1116155 00606959067578

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown