BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE

    MDR report key: 24284348 · Received February 6, 2026

    Report

    Report Number
    1417592-2026-00095
    Event Type
    Injury
    Date Received
    February 6, 2026
    Date of Event
    December 1, 2025
    Report Date
    February 6, 2026
    Manufacturer
    MEDLINE INDUSTRIES, LP
    Product Code
    BTM
    UDI-DI
    10884389126042
    PMA / PMN Number
    K012842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2025, IT WAS REPORTED THAT A MEDLINE ADJUSTABLE PEEP VALVE USED DURING IPV AIRWAY CLEARANCE THERAPY DID NOT MAINTAIN THE INTENDED PEEP AFTER ONE TO TWO TREATMENT CYCLES. THE PATIENT WAS RECEIVING IPV EVERY FOUR HOURS IN THE PCICU. STAFF NOTED THAT THE FLOW AND PEEP OUTPUT DID NOT SOUND APPROPRIATE. UPON INSPECTION, THE RESPIRATORY THERAPIST FOUND THAT THE INTERNAL SPRING OF THE PEEP VALVE WAS LOOSE AND THE ADJUSTMENT KNOB ROTATED TOO FREELY, INDICATING THE DEVICE WAS UNABLE TO HOLD PRESSURE AS INTENDED. THE INABILITY TO MAINTAIN PEEP DURING TREATMENT RESULTED IN DE-RECRUITMENT AND THERAPY WAS CHANGED TO AN ALTERNATIVE MODALITY THAT DID NOT RELY ON PEEP. THE PATIENT DEMONSTRATED IMPROVEMENT FOLLOWING THIS CHANGE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE FACILITY ON (B)(6) 2025, IT WAS REPORTED THAT A MEDLINE ADJUSTABLE PEEP VALVE USED DURING IPV AIRWAY CLEARANCE THERAPY DID NOT MAINTAIN THE INTENDED PEEP AFTER ONE TO TWO TREATMENT CYCLES. THE PATIENT WAS RECEIVING IPV EVERY FOUR HOURS IN THE PCICU. STAFF NOTED THAT THE FLOW AND PEEP OUTPUT DID NOT SOUND APPROPRIATE. UPON INSPECTION, THE RESPIRATORY THERAPIST FOUND THAT THE INTERNAL SPRING OF THE PEEP VALVE WAS LOOSE AND THE ADJUSTMENT KNOB ROTATED TOO FREELY, INDICATING THE DEVICE WAS UNABLE TO HOLD PRESSURE AS INTENDED. THE INABILITY TO MAINTAIN PEEP DURING TREATMENT RESULTED IN DE-RECRUITMENT AND THERAPY WAS CHANGED TO AN ALTERNATIVE MODALITY THAT DID NOT RELY ON PEEP. THE PATIENT DEMONSTRATED IMPROVEMENT FOLLOWING THIS CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341296 MEDLINE VALVE,PEEP,19MM ADJSTIBLE,W/30MM ADAPTER BTM MEDLINE INDUSTRIES, LP 10884389126042

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other