BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 24818800 · Received April 8, 2026

    Report

    Report Number
    1314417-2026-00020
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    February 3, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BOUND TREE MEDICAL, LLC
    Product Code
    BTM
    UDI-DI
    00812277037029
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CODE (A): 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): RESUSCITATION BAG W/MASK. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. 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 APR 2026 HAS BEEN INCLUDED IN THE 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 IS 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 A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CARDIAC ARREST RESPONSE ON (B)(6) 2026, A PARAMEDIC NOTED THE POP OFF VALVE WAS MISSING WHEN THEY RETRIEVED THE FIRST BAG VALVE MASK (BVM). THE PARAMEDIC IMMEDIATELY SWITCHED TO ANOTHER BVM FROM AVAILABLE STOCK AND WAS ABLE TO COMPLETE THE CALL WITHOUT ISSUE. THERE WERE NO REPORTS OF HARM OR INJURY RESULTING FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373160 CURAPLEX CURAPLEX SMALL ADULT/PEDIATRIC PREMIUM BVM W/ BAG RESERVOIR, MANOMETER, 25CM BTM BOUND TREE MEDICAL, LLC AF2000 UNKNOWN 00812277037029

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown