BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 14215336 · Received April 26, 2022

    Report

    Report Number
    2031642-2022-01105
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    April 21, 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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTING INSTITUTION PHONE NUMBER : (B)(6).

    Additional Manufacturer Narrative · 0

    THE SOFTWARE VERSION WAS CONFIRMED TO BE 2.30. PER THE SALES REPRESENTATIVE, THE TYPE OF BREATHING CIRCUIT THAT WAS USED WAS AN IS DISPOSABLE CIRCUIT WITH WTP(F15) MG5819175. PER THE CLARIFICATION OBTAINED IN REGARDS TO THE FINDINGS OF "OPEN STATUS DURING RUN, SO IT WAS THOUGHT THAT THE REPORTED PHENOMENON HAD BEEN MALFUNCTION FAILURE", THE REPORTER INDICATED THAT ACCORDING TO THE TECHNICIAN, A V60 GENERATES E1111 WHEN THE LEAK AMOUNT HAS EXCEEDED ITS PRESCRIBED TOLERANCE DUE TO RELEASING THE CIRCUIT AND SUCH EVEN IF THE DEVICE IS IN NORMAL STATUS. THE TECHNICIANS HAVE ALSO CONFIRMED THAT THE ERROR OFTEN OCCURS WHEN THE FIO2 SETTING IS AROUND 22-23%. THE EVALUATION STATED THAT AT THE TIME OF REPORTING, THIS WAS THE NOTED DEVICE BEHAVIOR, AND IT WAS NOT AN ACTUAL MALFUNCTION WHICH REQUIRED REPLACEMENT OF A PART. THE REPORTED ISSUE COULD NOT BE CONFIRMED.SINCE THE REPAIR WAS CANCELED BY THE CUSTOMER, THE UNIT WAS RETURNED TO THE CUSTOMER WITHOUT BEING SERVICED.

    Additional Manufacturer Narrative · 0

    A MALE PATIENT OF UNKNOWN AGE AND MEDICAL HISTORY WAS PRESCRIBED V60 VENTILATOR (SOFTWARE VERSION >2.30), WITH THE FOLLOWING SETTINGS, ALARMS LIMITS AND CONFIGURATIONS: S/T MODE; I-TIME 1.00; RISE 3; TRIGGER NORMAL; CYCLE NORMAL; IPAP/PS 14; FIO2 60%; RESPIRATORY RATE 16, EPAP/PEEP 6; HIGH RATE 60; HIGH PRESSURE 50; LOW RATE 4; LOW PRESSURE 6; HIGH VT 1000; LOW VE 0.3; LOW VT OFF AND ALARM ESCALATION OFF, FOR AN UNKNOWN INDICATION. ON 21-APR-2022 AT 16:40 DURING CLINICAL USE, THE DEVICE GENERATED AN AUDIBLE ALARM OF "OXYGEN NOT AVAILABLE" WHICH RESULTED IN PATIENT DECREASED PERIPHERAL CAPILLARY OXYGENATION (SPO2) TO 70%. THE UNIT WAS REPLACED WITH THE SAME V60 MODEL WITHIN 10 MINUTES AFTER THE OCCURRENCE OF THE EVENT. THE SPO2 IMPROVED TO 98% AFTER THE UNIT WAS REPLACED. THE UNIT HAS JUST ARRIVED AT THE INSTITUTIONAL SERVICE CENTER AND IS AWAITING EVALUATION FROM THE SERVICE TECHNICIAN.

    Description of Event or Problem · 0

    A MEDICAL ENGINEER (ME) REPORTED ON (B)(6) 2022 THAT WHILE A V60 VENTILATOR WAS IN CLINICAL USE, THE DEVICE GENERATED AN "OXYGEN NOT AVAILABLE" ALARM. A MALE PATIENT OF UNKNOWN AGE AND MEDICAL HISTORY WAS PLACED ON A V60 VENTILATOR FOR AN UNSPECIFIED INDICATION. ON (B)(6) 2022 AT 16:40, THE ME REPORTED THAT THE DEVICE GENERATED AN AUDIBLE ALARM OF "OXYGEN NOT AVAILABLE" WHICH RESULTED IN DECREASED PERIPHERAL CAPILLARY OXYGENATION (SPO2), WITH VALUE NOT SPECIFIED. THE UNIT WAS REPLACED WITH THE SAME V60 MODEL WITHIN 10 MINUTES AFTER THE OCCURRENCE OF THE EVENT. THERE WAS NO OTHER MEDICAL INTERVENTION RENDERED OTHER THAN REPLACING THE UNIT. THERE WAS NO FURTHER HARM INCURRED, AND NO DELAY IN THERAPY WAS REPORTED BECAUSE OF THE FAILURE. SUBSEQUENT INFORMATION RECEIVED FROM A NURSE INDICATED THAT PATIENT OUTCOME HAS IMPROVED ON THE SAME DAY OF THE EVENT ((B)(6) 2022). THE NURSE STATED THAT THE CAUSALITY BETWEEN THE UNIT AND THE EVENT WAS THAT THE PATIENT¿S LOWERED SPO2 WAS LIKELY RELATED TO "OXYGEN NOT AVAILABLE" ALARM. ON (B)(6) 2022, AT 19:00, THE SALES REPRESENTATIVE CHECKED THE ALARM LOG AND CONFIRMED THAT "OXYGEN NOT AVAILABLE"(1208) ALARM AND "OXYGEN DEVICE FAILED" (1111) ALARM HAVE BEEN RECORDED AT 04:21. THE MALFUNCTIONING V60 VENTILATOR WAS COLLECTED BY THE SALES OFFICE. A RUN-IN TEST WAS PERFORMED; HOWEVER, THE REPORTED PHENOMENON WAS NOT DUPLICATED. THE CURRENT DISPOSITION OF THE UNIT WAS NOT REPORTED. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION AND THE ROOT CAUSE COULD NOT BE DETERMINED AS THE ISSUE COULD NOT BE DUPLICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554579 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 Male Required Intervention