BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNMED LLC

    MDR report key: 19397864 · Received May 24, 2024

    Report

    Report Number
    1314417-2024-00023
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 8, 2024
    Report Date
    June 27, 2024
    Manufacturer
    SUNMED HOLDINGS LLC
    Product Code
    BTM
    UDI-DI
    10888277628298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 24 MAY 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 AIRLIFE. 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 AIRLIFE. AIRLIFE. 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 AIRLIFE 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 AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 24 MAY 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 AIRLIFE. 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 AIRLIFE. AIRLIFE. 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 AIRLIFE 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 AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE COMPLAINT OF "BAG BODY BROKE AWAY FROM THE PATIENT PORT" REGARDING PART CPRM1116FM WAS CONFIRMED. THE ROOT CAUSE COULD POSSIBLY BE A RESULT OF THE PORT NOT BEING FULLY INSERTED INTO THE BAG DURING ASSEMBLY. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM WHICH DOES REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 0 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THE REPORTING OF THIS ISSUE. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Description of Event or Problem · 0

    RESUSCITATION BAGS THAT BROKE AWAY FROM THE BAG PART.

    Description of Event or Problem · 0

    RESUSCITATION BAGS THAT BROKE AWAY FROM THE BAG PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643867 SUNMED LLC ADULT RESUS W/MASK, BAG RESERVOIR, FILTER & MANOMETER BTM SUNMED HOLDINGS LLC CPRM1116FM 461276 10888277628298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other