BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED HOLDINGS LLC

    MDR report key: 21542403 · Received March 6, 2025

    Report

    Report Number
    1314417-2025-00011
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Report Date
    May 28, 2025
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    CAH
    UDI-DI
    10884389120453
    PMA / PMN Number
    K033008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G1. NO PHYSICAL SAMPLE, PHOTO IMAGE, OR VIDEO WERE PROVIDED BY THE REPORTER; THEREFORE, THE COMPLAINT WAS NOT CONFIRMED. THE SUPPLIER REVIEWED THE DEVICE HISTORY RECORD; NO FINDINGS WERE NOTED DURING REVIEW. ALL INFORMATION REASONABLY KNOWN AS OF 28 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 (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 PRODUCT INVOLVED IN THE REPORT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 06 MAR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PATIENT'S VENTILATOR ALARMED, THE PATIENT WAS REMOVED FROM THE VENT AND ATTEMPTS WERE MADE TO PROVIDE VENTILATION WITH AN AMBU-BAG. ADDITIONALLY, THE HEAT AND MOISTURE EXCHANGER (HME) WAS REMOVED FROM THE VENT CIRCUIT AND HOOKED TO THE EXPIRATORY FILTER OUTLET ON THE AMBU-BAG, THE OTHER END OF THE HME WAS HOOKED TO THE ENDOTRACHEAL TUBE (ETT) AND THE EXPIRATORY PORT ON THE AMBU-BAG WAS LEFT OPEN; AS A RESULT, THE PATIENT DID NOT RECEIVE THE INTENDED BREATHS. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE PATIENT'S VENTILATOR ALARMED, THE PATIENT WAS REMOVED FROM THE VENT AND ATTEMPTS WERE MADE TO PROVIDE VENTILATION WITH AN AMBU-BAG. ADDITIONALLY, THE HEAT AND MOISTURE EXCHANGER (HME) WAS REMOVED FROM THE VENT CIRCUIT AND HOOKED TO THE EXPIRATORY FILTER OUTLET ON THE AMBU-BAG, THE OTHER END OF THE HME WAS HOOKED TO THE ENDOTRACHEAL TUBE (ETT) AND THE EXPIRATORY PORT ON THE AMBU-BAG WAS LEFT OPEN; AS A RESULT, THE PATIENT DID NOT RECEIVE THE INTENDED BREATHS. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391287 SUNMED HOLDINGS LLC EXCHANGER,HEAT/MOIST,SM,NO PORT CAH SUNMED HOLDINGS LLC DYNJAAHME12 40020080063 10884389120453

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown