BEUDAMED
    FDA Adverse Event Death Summary report: N

    LAERDAL SUCTION UNIT

    MDR report key: 23029462 · Received September 11, 2025

    Report

    Report Number
    3002807435-2025-00001
    Event Type
    Death
    Date Received
    September 11, 2025
    Date of Event
    August 13, 2025
    Report Date
    October 6, 2025
    Manufacturer
    LAERDAL MEDICAL A/S
    Product Code
    BTA
    PMA / PMN Number
    K993668
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN ACCORDANCE WITH 21 CFR §803.56 AND FDA MDR GUIDANCE ON FOLLOW-UP REPORTING, LAERDAL HAS MADE GOOD-FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THIS EVENT. EIGHT DOCUMENTED OUTREACH ATTEMPTS THROUGH PHONE AND EMAIL WERE MADE BY LAERDAL WITHOUT RESPONSE FROM THE COMPLAINANT. IT IS THEREFORE NOT POSSIBLE TO CONFIRM THE EXACT FAILURE OF THE PRODUCT. BASED ON THE INITIAL CUSTOMER COMPLAINT, IT IS LIKELY THAT THE BATTERY WAS NOT WORKING. IT IS UNKNOWN HOW OLD THE BATTERY WAS AT THE TIME OF INCIDENT. BATTERY PERFORMANCE IS DEPENDENT ON AGE, USE AND CHARGING REGIME. IT IS LIKELY THAT THE CUSTOMER HAS NOT PERFORMED THE BATTERY TEST AS DESCRIBED IN USER GUIDE. ALTERNATIVE SUCTION METHODS ARE AVAILABLE TO THE CLINICIAN IN THE CASE OF DEVICE FAILURE. DELAY OF SUCTION TREATMENT IS CONSIDERED TO HAVE LOW SEVERITY.

    Description of Event or Problem · 0

    AN EMS CUSTOMER REPORTED THAT A LAERDAL SUCTION UNIT (LSU) WITH A BEMIS CANNISTER FAILED TO SUCTION WHILE OPERATING ON BATTERY POWER DURING TREATMENT OF A PATIENT UNABLE TO BREATHE. THE UNIT FUNCTIONED WHEN PLUGGED IN, BUT NOT ON BATTERY POWER. THE PATIENT DIED DURING THE EVENT. THE INCIDENT OCCURRED IN THE U.S. LAERDAL IS INVESTIGATING AND HAS REQUESTED A COMPLETED PATIENT QUESTIONNAIRE AND RETURN OF THE DEVICE FOR EVALUATION. AS OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE INCIDENT, THE BATTERY USED, DEVICE SERVICING, OR PRE-USE DEVICE TESTING.

    Description of Event or Problem · 0

    AN EMS CUSTOMER REPORTED THAT A LAERDAL SUCTION UNIT (LSU) WITH A BEMIS CANNISTER FAILED TO SUCTION WHILE OPERATING ON BATTERY POWER DURING TREATMENT OF A PATIENT UNABLE TO BREATHE. THE UNIT FUNCTIONED WHEN PLUGGED IN, BUT NOT ON BATTERY POWER. THE PATIENT DIED DURING THE EVENT. THE INCIDENT OCCURRED IN THE U.S. LAERDAL IS INVESTIGATING AND HAS REQUESTED A COMPLETED PATIENT QUESTIONNAIRE AND RETURN OF THE DEVICE FOR EVALUATION. AS OF THIS REPORT, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THE INCIDENT, THE BATTERY USED, DEVICE SERVICING, OR PRE-USE DEVICE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2676049 LAERDAL SUCTION UNIT EMERGENCY AIRWAY CLEARANCE SUCTION SYSTEM, ELECTRIC BTA LAERDAL MEDICAL A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death