BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE MEDICAL, INC.

    MDR report key: 20418045 · Received October 10, 2024

    Report

    Report Number
    8030673-2024-01028
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 11, 2024
    Report Date
    November 26, 2024
    Manufacturer
    VYARIE MEDICAL
    Product Code
    CAI
    UDI-DI
    00709078014758
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 10 OCT 2024 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 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.

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE, FROM THE REPORTED EVENT WAS RETURNED AND EVALUATED, NO ISSUES WERE OBSERVED ON DEVICE. SINCE THE REPORTED FAILURE WAS NOT REPRODUCED IN THE LAB DURING SAMPLE EVALUATION THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR LOT 0004291027 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 26 NOV 2024 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.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030673-2024-01029 FOR THE SECOND REPORT REFER TO 8030673-2024-01030 FOR THE THIRD REPORT THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) REPORTED, DURING BAGGING OF THE PATIENT, THE BREATHING BAG SLIPPED OFF THE ANESTHESIA MACHINE CONNECTOR (FOR AN UNSPECIFIED PERIOD OF TIME). TO REMEDY THE ISSUE IT WAS REPORTED, WHEN THE SLIPPAGE OCCURRED THE BREATHING BAG WAS PUSHED AS FAR UP ON THE CONNECTOR AS POSSIBLE AND THEY WERE MORE DILIGENT ABOUT THEIR PLACEMENT ON THE GAS MACHINE CONNECTION; THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030673-2024-01029 FOR THE SECOND REPORT. REFER TO 8030673-2024-01030 FOR THE THIRD REPORT. THE CERTIFIED REGISTERED NURSE ANESTHETIST (CRNA) REPORTED, DURING BAGGING OF THE PATIENT, THE BREATHING BAG SLIPPED OFF THE ANESTHESIA MACHINE CONNECTOR (FOR AN UNSPECIFIED PERIOD OF TIME). TO REMEDY THE ISSUE IT WAS REPORTED, WHEN THE SLIPPAGE OCCURRED THE BREATHING BAG WAS PUSHED AS FAR UP ON THE CONNECTOR AS POSSIBLE AND THEY WERE MORE DILIGENT ABOUT THEIR PLACEMENT ON THE GAS MACHINE CONNECTION; THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189685 VYAIRE MEDICAL, INC. VITAL SIGNS BREATHING BAG CAI VYARIE MEDICAL 5063NL; 5610004 0004291027 00709078014758

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown