BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAPLEX

    MDR report key: 23790271 · Received December 12, 2025

    Report

    Report Number
    1314417-2025-00103
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Report Date
    February 13, 2026
    Manufacturer
    SUNMED AP, LTD.
    Product Code
    BTM
    UDI-DI
    00812277035322
    PMA / PMN Number
    NA
    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

    CODE (A): 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): RESUSCITATION BAG W/MASK THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 12 DEC 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

    CODE (A): 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): RESUSCITATION BAG W/MASK. CORRECTIONS WERE MADE TO THE FOLLOWING FIELDS: B5; D9. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR PHYSICAL EVALUATION; HOWEVER, THE REPORTER PROVIDED PHOTOGRAPHIC EVIDENCE FOR REVIEW. ANALYSIS OF THE SUBMITTED PHOTO CONFIRMED THE REPORTED DEFECT. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS INSUFFICIENT BONDING STRENGTH OF THE UPPER COVER. THIS CONDITION WAS ATTRIBUTED TO AN INADEQUATE HEIGHT OF THE ULTRASONIC WELDING LINE, WHICH RESULTED IN INCOMPLETE OR WEAKENED BONDING DURING ASSEMBLY. INTERIM COUNTERMEASURES (IMPLEMENTED SEPTEMBER 2025): REDUCED THE UPPER LIMIT OF THE WELDING HEIGHT SPECIFICATION TO INCREASE WELDING STRENGTH AND IMPROVE BOND INTEGRITY. IMPLEMENTED AN ADDITIONAL IN PROCESS INSPECTION TO VERIFY TENSILE STRENGTH OF THE WELD DURING PRODUCTION. PERMANENT COUNTERMEASURE: THE DESIGN OF THE UPPER COVER WAS MODIFIED TO INCREASE THE HEIGHT OF THE ULTRASONIC WELDING LINE. MOLD ADJUSTMENTS HAVE BEEN COMPLETED, AND VERIFICATION ACTIVITIES ARE CURRENTLY IN PROGRESS TO CONFIRM EFFECTIVENESS AND PROCESS CAPABILITY. A REVIEW OF COMPLAINT HISTORY IDENTIFIED ONE COMPLAINT INVOLVING THE SAME PART NUMBER WITHIN 24 MONTHS. NO ADDITIONAL TRENDS WERE IDENTIFIED; MONITORING WILL CONTINUE FOR ANY EMERGING TRENDS. THE DEVICE HISTORY RECORD FOR LOT 0004315927 WAS REVIEWED, AND CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 13 FEB 2026 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 INFORMATION KNOWN 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 PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE 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 AIRLIFE PRODUCT WAS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CARDIAC ARREST EVENT, THE BAG VALVE MASK (BVM) BROKE INTO THREE PIECES WHEN REMOVED FROM ITS PACKAGING. THIS IS THE THIRD INSTANCE OBSERVED WHERE BVMS FROM THE CUSTOMER'S STOCK HAVE EXHIBITED THIS ISSUE. THERE WERE NO REPORTS OF HARM, INJURY, OR DELAY IN THERAPY ASSOCIATED WITH THIS EVENT. SUNMED HOLDINGS LLC RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 1314417-2025-00101 FOR THE FIRST REPORT. REFER TO 1314417-2025-00102 FOR THE SECOND REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A CARDIAC ARREST EVENT, THE BAG VALVE MASK (BVM) BROKE INTO THREE PIECES WHEN REMOVED FROM ITS PACKAGING. THIS IS THE THIRD INSTANCE OBSERVED WHERE BVMS FROM THE CUSTOMER'S STOCK HAVE EXHIBITED THIS ISSUE. THERE WERE NO REPORTS OF HARM, INJURY, OR DELAY IN THERAPY ASSOCIATED WITH THIS EVENT. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS AND INVOLVED DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 1314417-2025-00101 FOR THE FIRST REPORT. REFER TO 1314417-2025-00102 FOR THE SECOND REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484387 CURAPLEX CURAPLEX BVM, ADULT, MASK SIZE 5, UNIVERSAL CONNECTOR, 7FT O2 TUBING BTM SUNMED AP, LTD. 301-BVM1500 0004315927 00812277035322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown