BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 21740276 · Received April 1, 2025

    Report

    Report Number
    2518422-2025-040729
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 24, 2025
    Report Date
    May 8, 2026
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (B)(6).

    Additional Manufacturer Narrative · 0

    THE REPLACED CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS RETURNED TO THE PHILIPS PRODUCT INVESTIGATION LAB (PIL) FOR EVALUATION BY A PIL TECHNICIAN (PIL TECH). TESTING OF THIS CPU WITH THE ACCUSATION OF A BACKUP ALARM FAILURE (ERROR CODE 1104) HAS BEEN ANALYZED. STEP 1; APPLY 10VDC (+/-2 VDC) DIRECTLY TO THE PINS OF LS1 WHILE ADHERING TO CIRCUIT POLARITY. STEP 2A; IF LS1 FAILS TO SOUND, THE LS1 HAS FAILED DUE TO COLD SOLDER JOINT(S) AND IS THE SAME FAILURE MODE AS DOCUMENTED IN CAPA 5120675. NO FURTHER TESTING REQUIRED. STEP 2B; IF LS1 DOES SOUND, INSTALL SUSPECT CPU PCBA INTO A KNOWN GOOD UNIT OR ON AN STB. PERFORM POWER FAILURE ALARM TEST AND POST IN VENTILATION MODE 3-5 TIMES. IF NO FAULTS ARE IDENTIFIED, STOP TESTING AND DOCUMENT ¿NO PROBLEM FOUND¿ IN THE INVESTIGATION. IF FAULTS WERE IDENTIFIED, TROUBLESHOOT AND INVESTIGATE THOSE MODES OF FAILURE AS NORMAL. THIS RETURNED CPU PCBA PART TESTING RESULTED IN NO PROBLEM BEING FOUND. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Description of Event or Problem · 0

    PHILIPS RECEIVED A COMPLAINT ON THE V60 VENTILATOR INDICATING THAT THERE WAS A BACKUP ALARM FAILED ALARM. THE DEVICE WAS REPORTED TO BE IN USE AT THE TIME OF THE REPORTED PROBLEM. NO PATIENT OR USER HARM REPORTED. THE CUSTOMER STATED THAT, FOLLOWING THE ALARM, THE DEVICE WAS REMOVED FROM SERVICE AND REPLACED WITH ANOTHER VENTILATOR OF THE SAME MODEL, A V60. THE DEVICE WAS COLLECTED BY A PHILIPS SALES REPRESENTATIVE AND BROUGHT TO A REPAIR CENTER TO BE EVALUATED BY AN AUTHORIZED SERVICE PROVIDER (ASP). THE ASP EVALUATED THE DEVICE ON 27MAR2025 AT THE REPAIR CENTER AND CONFIRMED THE OCCURRENCE OF THE BACKUP ALARM FAILED ALARM IN THE DEVICE DIAGNOSTIC REPORT (DRPT) BUT COULD NOT REPRODUCE THE ALARM WHEN EVALUATING THE DEVICE. AS A PREVENTATIVE MEASURE, THE CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) WAS REPLACED FOLLOWING THE PART REPLACEMENT, THE ASP COMPLETED A CLEANING, RUNNING TEST, AND A FUNCTION TEST. TO CONFIRM THAT THE DEVICE WAS RETURNED TO FULL FUNCTIONALITY. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464289 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS, INC. V60 V60PLUS VENTILATOR 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1