BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 14787399 · Received June 23, 2022

    Report

    Report Number
    2031642-2022-01669
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    June 15, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838033832
    PMA / PMN Number
    K102985
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THE DEVICE'S INOPERABILITY, THE PATIENT WAS IN A PRONE POSITION. THE DEVICE GENERATED A CONTINUOUS AUDIBLE HIGH-PRESSURE ALARM, AND THE SAME MESSAGE WAS ALSO DISPLAYED ON THE SCREEN, THEN THE UNIT SHUT DOWN. THE AUTO-TRAK+ OPTION WAS INSTALLED ON THE VENTILATOR AT THE TIME OF THE INCIDENT. IT WAS UNKNOWN IF THE ALARM VOLUME ESCALATION FEATURE WAS ENABLED WHEN THE REPORTED EVENT OCCURRED. THE CUSTOMER WAS UNABLE TO MONITOR THE PRESSURE. THERE WAS NO CONDENSATION, WATER DROPLETS, KINKS, OR OBSTRUCTIONS NOTED WITHIN THE PROXIMAL PRESSURE LINE. THERE WAS ONLY ONE BACTERIAL FILTER IN USE. THE SALES REPRESENTATIVE WAS UNABLE TO CONFIRM THE VENTILATOR THERAPY AND ALARM THRESHOLD SETTINGS AS THE DEVICE WAS RETURNED TO THEIR SALES OFFICE AFTER THE REPAIR WAS COMPLETED. THE CUSTOMER STATED THAT THE PATIENT HAD DELIRIUM AND ATTEMPTED TO REMOVE THE MASK SEVERAL TIMES, AND AS A RESULT, THE SPO2 VALUE DROPPED TO THE 60% LEVEL. AT THE TIME OF EVENT RESOLUTION, THE SPO2 LEVEL WAS >60%. THE SOFTWARE WAS CONFIRMED TO BE VERSION 2.30. THE CUSTOMER PROVIDED THE FOLLOWING DESCRIPTION OF THE CIRCUIT CONFIGURATIONS BEING USED: WHICH INCLUDED THE MAKE, MODEL, AND SIZES: A. BREATHING CIRCUIT #1 MANUFACTURER: INTER SURGICAL, PRODUCT NAME: SMOOTH-BOR, ADULT 0.6M SINGLE USE CIRCUIT, CODE# 50506600 #2 MANUFACTURER: INTER SURGICAL, PRODUCT NAME: SMOOTH-BOR, EXHALATION PORT, CODE# 5804000 #3 MANUFACTURER: INTER SURGICAL, PRODUCT NAME: AUTOMATIC WATER SUPPLY CHAMBER, CODE# 2310000 #4 MANUFACTURER: PACIFIC MEDICO , PRODUCT NAME: BREEZING SYSTEM (PROXIMAL FILTER) , CODE# 50506600 #5 MANUFACTURER: MAKIGUCHI RUBBER CO.LD, PRODUCT NAME: MRC TUBE 15M #6 MANUFACTURER: JAPAN BECTON, DICKINSON, PRODUCT NAME: KOMA FILTER JUNI (DISK TYPE FILTER) , CODE# M1003346 B. HUMIDIFIER: MANUFACTURER: I.M., PRODUCT NAME: PHM-1000, CODE#70562000 OVERALL, CHECKING, CLEANING, TEST RUN, AND FUNCTIONALITY TESTS WERE PERFORMED, AND THE REPORTED PHENOMENON WAS NOT DUPLICATED DESPITE A TEST RUN. THE EVENT LOG REVEALED THAT "VENT INOPERATIVE ERROR PRESSURE REGULATION HIGH" (DIAGNOSTIC CODE 1009) HAD OCCURRED ON 14-JUN-2022 AT 2:58 PM. OTHER THAN 1009, THERE WAS NO LOG THAT SHOWED AN ANOMALY IN THE DEVICE. THE DEVICE WAS CHECKED, BUT NO ANOMALY WAS OBSERVED. BASED ON THE INFORMATION PROVIDED, PHILIPS IS UNABLE TO CONFIRM THE DEVICE ISSUE AS THE SYMPTOM COULD NOT BE DUPLICATED.

    Additional Manufacturer Narrative · 0

    DEVICE SETTINGS INCLUDED ST: 8/4, RR 12, RISE, 1, TI 1.0 FIO2 100%. AT THE TIME OF THE DEVICE INOPERABILITY, THE PATIENT WAS IN A PRONE POSITION. THE DEVICE GENERATED CONTINUOUS PRESSURE REGULATION HIGH ALARM, AND THE SAME MESSAGE ALSO DISPLAYED ON THE SCREEN, THEN THE UNIT SHUTDOWN. BASED ON THE OUTCOME OF DEVICE EVALUATION, NO DEVICE ANOMALY WAS FOUND AND FULL FUNCTIONALITY WAS CONFIRMED. THE DIAGNOSTIC CODE OF 1009 ASSOCIATED WITH VENTILATOR INOPERABILITY IS A SAFETY MECHANISM THAT TRIGGERS THE VENTILATOR TO SHUT DOWN TO PROTECT THE PATIENT FROM HIGH INHALATION PRESSURE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONFIRMED THAT THERE WERE NO KINKS IN THE BREATHING CIRCUITS.

    Description of Event or Problem · 0

    THE MEDICAL ENGINEER (ME) REPORTED TO A SALES REPRESENTATIVE THAT THE DEVICE ANNUNCIATED "PRESSURE REGULATION HIGH" ALARM, BECAME INOPERATIVE AND SHUTDOWN. A PATIENT OF UNKNOWN AGE, GENDER, AND MEDICAL HISTORY WAS ON A V60 VENTILATOR (VERSION 2.30; UNKNOWN SETTINGS AND CONFIGURATIONS) FOR AN UNSPECIFIED INDICATION. ON (B)(6) 2022 AT 3:15 PM, WHILE THE DEVICE WAS IN CLINICAL USE, IT ANNUNCIATED ¿PRESSURE REGULATION HIGH" ALARM, BECAME INOPERATIVE AND SHUTDOWN. AS A RESULT, THE PATIENT¿S PERIPHERAL CAPILLARY OXYGEN SATURATION (SPO2) VALUE DECREASED TO 60% RANGE. THE AUTO-TRAK+ OPTION WAS INSTALLED ON THE VENTILATOR AT THE TIME OF THE INCIDENT. WHEN THE DEVICE WAS REBOOTED AND RESTARTED, IT QUICKLY STARTED WITH THE SAME SETTINGS. HOWEVER, THE ME REPLACED THE DEVICE WITH ANOTHER V60 VENTILATOR. NO FURTHER MEDICAL INTERVENTION NOR DELAY IN THERAPY WAS REPORTED. THE PATIENT RECOVERED ON (B)(6) 2022. THE ME STATED THAT THE PATIENT WOULD ALWAYS TAKE THE MASK OFF AND THE SPO2 OFTEN DECREASED TO 50% RANGE. THEREFORE, THE ME DETERMINED THAT THERE WAS NO NEGATIVE IMPACT FROM THE INOPERATIVE DEVICE. A DEVICE EVALUATION WILL BE PERFORMED BY A PHILIPS TECHNICIAN IN THE REPAIR CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290462 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, JAPAN OPT: CFLEX,AVAPS,AT+ 00884838033832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention