BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11852514 · Received May 19, 2021

    Report

    Report Number
    2031642-2021-03769
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 20, 2021
    Product Code
    MNT
    PMA / PMN Number
    K053168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G5:510(K)#: K053168. B4: (B)(6) 2021. THE BIOMEDICAL ENGINEER (BIOMED) STATED UNIT WAS CHARGING OVER 24 HOURS; UNIT HAD A LOAD TEST AND FAILED LOAD 40-MINUTE TEST. THE BATTERY WAS REPLACED IN JAN 2021. THE BIOMED WAS THINKING THIS MAY HAVE BEEN A BAD BATTERY. HE REPLACED THE BATTERY CHARGE OVERNIGHT AND THE 2ND NEW BATTERY DID NOT WORK EITHER. THE PCB WOULD NOT CHARGE AND IS NOT WORKING. (NO PARTS AVAILABLE) THE BIOMED RAN MULTIPLE TESTS WITH SEVERAL NEW BATTERIES AND AFTER REPLACING THE POWER CORD AND EXTERNAL POWER BRICK. THE UNIT FAILED TO LOAD TEST EACH TIME. THE UNIT HAS PASSED ITS END OF LIFE DATE AND NO PARTS ARE AVAILABLE. THE CUSTOMER HAS RETIRED THIS UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS BY A CUSTOMER THAT THE UNIT WILL NOT PASS THE BATTERY LOAD TEST. BASED UPON THE INFORMATION PROVIDED, THE DEVICE WAS NOT IN CLINICAL USE OR PROVIDING THERAPY AT THE TIME OF THE EVENT REPORTED. NO HARM OR INJURY HAS BEEN INDICATED OR ALLEGED. THE DEVICE WAS EVALUATED REMOTELY BY A PHILIPS REMOTE SERVICE ENGINEER (RSE) AND INFORMED THE CUSTOMER THAT THE UNIT HAD REACHED IT'S EOL IN 2019. THE CUSTOMER WAS AWARE AND IS SOURCING BATTERIES FROM A 3RD PARTY BUT THAT THEY WORK FINE IN OTHER UNITS. THE RSE ADVISED THE CUSTOMER TO ALLOW THE BATTERIES TO FULLY CHARGE IN THIS UNIT, THEN DEPLETE THEM AND ALLOW THEM TO FULLY CHARGE IN A KNOWN GOOD UNIT COMPARING THE VOLTAGE AT THE END OF THE CHARGE CYCLE. IF VOLTAGES ARE COMPARABLE TO SUSPECT THE BATTERIES ARE FAULTY OR NOT COMPATIBLE. THE RSE PROVIDED A FOCUS DISCONTINUATION LETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746432 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT BI-PAP FOCUS SYSTEM, USA

    Patients

    Seq Age Sex Outcome Treatment
    1