BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 12682568 · Received October 22, 2021

    Report

    Report Number
    2031642-2021-05360
    Event Type
    Injury
    Date Received
    October 22, 2021
    Date of Event
    September 24, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020047
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS IN USE. THE UNIT WAS SWAPPED OUT. THE PATIENT'S SPO2 DROPPED 20-30%. THE CUSTOMER REPLACED THE DATA ACQUISITION (DA) BOARD AT THE RECOMMENDATION THE OF PHILIPS REPRESENTATIVE. THE UNIT WAS TESTED AND IT WAS RETURNED TO SERVICE. DATA ACQUISITION (DA) PCBA WAS RETURNED TO THE MANUFACTURER FOR FAILURE ANALYSIS. A PHILIPS SENIOR TECHNICIAN COMPLETED A FAILURE INVESTIGATION ON 12-MAR-2022 AND PROVIDED THE FOLLOWING RESULTS: VISUAL INSPECTION OF THE DATA ACQUISITION (DA) PCBA REVEALED NO EVIDENCE OF DAMAGE OR CONTAMINATION. THE DATA ACQUISITION PCBA WAS INSTALLED IN THE FI TEST VENTILATOR (TN- TN-33249867) IN AN ATTEMPT TO DUPLICATE THE REPORTED PROBLEM. THE TEST VENTILATOR POWERED UP FROM AC AND DELIVERED BREATHS. IT PASSED PRESSURE ACCURACY TEST AND OPERATED FOR 1 HOUR WITHOUT FAILURES. THE POST WAS EXECUTED 25 TIMES WITHOUT GENERATING ANY FAILURES. THE TEST VENTILATOR DID NOT GENERATE 1009 DIAGNOSTIC ERROR CODE. BASED UPON THE INFORMATION PROVIDED, NO DEVICE MALFUNCTION OR FAILURE TO PERFORM TO MANUFACTURER SPECIFICATIONS HAS BEEN FOUND. THE DATA ACQUISITION PCBA WAS TESTED, AND NO FAILURES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AT 11: 52 AM, THE PATIENT'S SPO2 DROPPED 20-30%. WALL OXYGEN (O2) ALSO DID NOT WORK AT THIS TIME. THE MACHINE WAS TURNED OFF AND THEN BACK ON. IT WORKED ONCE TURNED BACK ON AND THE PATIENT'S (O2) DID RECOVER TO >90 % WITH 4 MINUTES.THE BIPAP WAS REPLACED BY THE RESPIRATORY THERAPIST (RT). THE UNIT WAS DELIVERING THERAPY. THERE WAS NO PATIENT HARM BECAUSE THE REGISTERED NURSE (RN) WAS AT BEDSIDE AND WITNESSED THIS ISSUE. AS PER REPORTER THE REMOTE SERVICE ENGINEER (RSE) RECOMMENDED REPLACEMENT OF THE DATA ACQUISITION (DA) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AS THIS MAYBE A CONTRIBUTOR TO THE DIAGNOSTIC ERROR " PRESSURE REGULATION HIGH (1009).

    Description of Event or Problem · 1

    THE BIOMEDICAL ENGINEER (BMED) REPORTED THAT THE ALARM SAYS NO OXYGEN DELIVERED, HIGH PRESSURE AND THE SCREEN WENT BLANK, AND THE UNIT SHUT DOWN WHILE IN USE. THE UNIT WAS SWAPPED OUT, THERE WAS NO PATIENT OR USER HARM REPORTED. THE (BMED) CONFIRMED THE REPORTED FAILURE. THE REGISTERED NURSE (RN) ADVISED THE THERAPIST THAT THE UNIT LOGGED A NO OXYGEN (O2) DELIVERED MESSAGE FOLLOWED BY A HIGH-PRESSURE ALERT AND SHUT DOWN WITH VENT INOPERATIVE DIAGNOSTIC ERROR "PRESSURE REGULATION HIGH". THE REMOTE SERVICE ENGINEER ADVISED (BMED) TO OPERATE THE UNIT ON A TEST LUNG AND THEN TO DISCONNECT THE PROXIMAL PORT, THE UNIT CONTINUED TO OPERATE. THE (RSE) ALSO ADVISED CUSTOMER TO INSPECT THE PROXIMAL PRESSURE PORTS AND THE MACHINE PRESSURE PORTS AND FOUND THAT THEY WERE CONNECTED CORRECTLY. THE (RSE) RECOMMENDED THE CUSTOMER PER TECH DISCRETION TO REPLACE THE DATA ACQUISITION BOARD AND TO COMPLETE FULL PERFORMANCE VERIFICATION TEST (PVT) AFTER REPLACEMENT. THE CUSTOMER REPLACED THE DATA ACQUISITION (DA) BOARD TO RESOLVE THE ISSUE. THE UNIT WAS TESTED AND IT WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577693 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown