BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE MEDICAL, INC

    MDR report key: 21989684 · Received May 8, 2025

    Report

    Report Number
    8030673-2025-00010
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    December 28, 2024
    Report Date
    June 30, 2025
    Manufacturer
    VYARIE MEDICAL
    Product Code
    LSZ
    UDI-DI
    0150190752159745
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: (APPROPRIATE TERM/CODE NOT AVAILABLE) INVESTIGATION FINDINGS: UNEXPECTED OR RANDOM COMPONENT FAILURE RELATED TO THE DESIGN. H6: (APPROPRIATE TERM/CODE NOT AVAILABLE) INVESTIGATION CONCLUSION: UNEXPECTED OR RANDOM COMPONENT FAILURE RELATED TO THE DESIGN. ANALYSIS OF PHOTOGRAPHIC EVIDENCE CONFIRMED THE CIRCUIT DISCONNECTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS REPORTED EVENT IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED; HOWEVER, A SAMPLE OF THE DEVICE HISTORY RECORDS WAS PERFORMED WHICH CONFIRMED THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. BASED ON THE ABOVE THE ROOT CAUSE WAS ESTABLISHED TO BE DESIGN RELATED. THE DOCUMENTED UDI IS BASED ON THE STOCK/PRODUCT CODE PROVIDED BY THE REPORTER; THE UDI-PI IS NOT AVAILABLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 08 MAY 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE FOLLOWING INITIAL FDA REPORT WAS SUBMITTED FOR THIS EVENT ON 25MAR2025_(B)(4).

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW: IT HAS BEEN DETERMINED, BASED ON THE MANUFACTURING AGREEMENT, AIR LIFE IS ONLY THE CONTRACT MANUFACTURER FOR THE DEVICE (PRODUCT CODE 29028-003) WHICH WAS REPORTED IN THIS COMPLAINT AND IS THEREFORE NOT RESPONSIBLE FOR REGULATORY REPORTING TO ANY COMPETENT AUTHORITY OR NOTIFIED BODY. NO ADDITIONAL REPORTS WILL BE SUBMITTED CONCERNING THE REPORTED EVENT BY AIR LIFE (A DIVISION OF SUN MED HOLDINGS LLC). ALL INFORMATION REASONABLY KNOWN AS OF 30 JUN 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED: WHILST ON [THE] PATIENT, [THE] OSCILLATOR ALARMED AS HAD STOPPED VENTILATION (DUMPED). INITIALLY UNABLE TO LOCATE PROBLEM AS THE BED SIDE NURSE TRIED TO PRESSURIZE THE CIRCUIT MULTIPLE TIMES WITHOUT SUCCESS[THE] PATIENT DESATURATED FROM MID 90S TO LATE 60S. IMMEDIATELY PLACED ON BAGGING CIRCUIT AND ABLE TO RECRUIT LUNGS BACK TO SATURATIONS OF EARLY TO MID-90S. DURING THIS TIME, A NEW OSCILLATOR WAS SET UP AND THE PATIENT WAS PLACED ON THE NEW OSCILLATOR AFTER PRE-USE CHECK UNEVENTFULLY. LATER NOTED TEMPERATURE WIRE TUBING WHERE CABLE TIE PRESENT, HAD BECOME DISCONNECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED: WHILST ON [THE] PATIENT, [THE] OSCILLATOR ALARMED AS HAD STOPPED VENTILATION (DUMPED). INITIALLY UNABLE TO LOCATE PROBLEM AS THE BED SIDE NURSE TRIED TO PRESSURIZE THE CIRCUIT MULTIPLE TIMES WITHOUT SUCCESS[THE] PATIENT DESATURATED FROM MID 90S TO LATE 60S. IMMEDIATELY PLACED ON BAGGING CIRCUIT AND ABLE TO RECRUIT LUNGS BACK TO SATURATIONS OF EARLY TO MID-90S. DURING THIS TIME, A NEW OSCILLATOR WAS SET UP AND THE PATIENT WAS PLACED ON THE NEW OSCILLATOR AFTER PRE-USE CHECK UNEVENTFULLY. LATER NOTED TEMPERATURE WIRE TUBING WHERE CABLE TIE PRESENT, HAD BECOME DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946390 VYAIRE MEDICAL, INC FLEXIBLE PATIENT CIRCUIT, 3100A MR850 IN HEATED ENVIRONMENT LSZ VYARIE MEDICAL 29028-003 UNKNOWN 0150190752159745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown