BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 17213178 · Received June 27, 2023

    Report

    Report Number
    2518422-2023-14356
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    June 18, 2023
    Report Date
    September 22, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    UDI-DI
    00884838033832
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: REPORTER PHONE NUMBER - 0120-556-494.

    Additional Manufacturer Narrative · 0

    THE REMOVED CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS RETURNED TO THE PRODUCT INVESTIGATION LAB (PIL) FOR ANALYSIS. NO ANOMALIES NOTED DURING A VISUAL INSPECTION OF THE COMPONENT. THE PIL TECHNICIAN INSTALLED THE SYSTEM CPU PCBA INTO A PIL V60 STANDARD TEST BED (STB) FOR TESTING. THE TECHNICIAN VERIFIED AN OCCURRENCE OF THE ERROR CODE FOR BACKUP ALARM FAILED (EC 1104) IN THE DEVICE ERROR LOGS. THE PIL TECHNICIAN WAS UNABLE TO DUPLICATE AN ASSOCIATED OCCURRENCE OR ERROR CODE EC 1104 DURING THE BOOT UP OF THE CPU PCBA OR STB OPERATION USING THE CPU PCBA. WITH THE TEST VENTILATOR IN A NO POWER/HARDWARE POWER FAIL STATE, THE PIL TECHNICIAN ALLOWED THE VISUAL AND AUDIBLE BACK UP ALARM TO OPERATE FOR A PERIOD OF 2 MINUTES. BOTH THE VISUAL AND AUDIBLE ALARMS OPERATED WITHOUT ISSUE. THE CPU PCBA PASSED ALL ENGINEERING TESTING AND ALL VOLTAGES REQUIRED FOR THE PROPER OPERATION OF THE SYSTEM ARE WELL WITHIN SPECIFICATION. LS1 RESISTANCE HAS BEEN MEASURED SHOWING A SOLID 397.7K OHMS, VERIFYING THAT LS1 IS NOT SHORTED OR OPEN. THE TECHNICIAN VERIFIED THAT LS1 (SECONDARY SPEAKER) FUNCTIONED AS EXPECTED WITH 10VDC APPLIED WITH THE BK PRECISION 1696 DC REGULATED POWER SUPPLY. THE TECHNICIAN PURPOSELY GENERATED AN ALARM CONDITION BY THE TEMPORARY DISCONNECT OF THE PPROX TUBE FROM THE PPROX PORT OF THE STB. THE TECHNICIAN VERIFIED THE ALARM FOR PPROX WAS GENERATED AS EXPECTED. THE INVESTIGATION OF THE CUSTOMER REPORTED ISSUE RESULTED IN A NO FAULT FOUND CONCLUSION.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER REPORTING A CHECK VENT: BACKUP ALARM FAILED OCCURRED ON THE V60 VENTILATOR. THE DEVICE WAS NOT IN CLINICAL USE. THERE WAS NO REPORT OF HARM. A MANUFACTURER'S PRODUCT SUPPORT ENGINEER (PSE) EVALUATED THE DEVICE AND REPORTED THE ISSUE COULD NOT DUPLICATED, HOWEVER, WAS CONFIRMED IN THE DEVICE EVENT LOG. THE PSE VERIFIED DIAGNOSTIC CODE 1104 (BACKUP ALARM FAILED). THE PSE REPLACED THE CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AS A RECURRENCE PREVENTIVE MEASURE. THE DEVICE WAS OPERATIONAL AFTER SERVICE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422912 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown