BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARKER

    MDR report key: 21426524 · Received February 20, 2025

    Report

    Report Number
    3000219639-2025-00020
    Event Type
    Death
    Date Received
    February 20, 2025
    Date of Event
    October 20, 2025
    Report Date
    April 8, 2025
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    PMA / PMN Number
    K984528
    Removal / Correction Number
    MW5165649
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): ENDOTRACEAL TUBE.THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 20 FEB 2025 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 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 A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. COMPLAINT WAS CONSIDERED CONFIRMED BASED ON CUSTOMER NARRATIVE OF EVENTS. A 24 MONTH REVIEW WAS CONDUCTED AND 49 ADDITIONAL COMPLAINTS WERE IDENTIFIED RELATED TO THIS ISSUE HOWEVER NO TREND WAS OBSERVED. THE PART AND LOT NUMBER WERE NOT PROVIDED, HOWEVER THE VENDOR WAS NOTIFIED OF THE INCIDENT. THIS INCIDENT WAS NOT IDENTIFIED AS AN INCREASING TREND. NO FURTHER ACTION TO BE TAKEN.

    Additional Manufacturer Narrative · 0

    H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): ENDOTRACEAL TUBE THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 20 FEB 2025 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

    PATIENT WAS SAT UP IN BED FOR A CHEST X-RAY. ET TUBE HAD BEEN IN PLACE SINCE (B)(6) 2025. SUDDEN CHANGE IN OXYGENATION AND VENTILATION NOTED. OBVIOUS CUFF LEAK. RN AND RT INJECTED 3 CC OF AIR WITH IMPROVEMENT AND THEN RAPID SOFTENING OF THE PILOT BALLOON. RECURRENCE OF OBVIOUS CUFF LEAK. UNABLE TO MAINTAIN CUFF PRESSURE. TUBE EMERGENTLY REPLACED. AFTER REINTUBATION, CARDIAC DYSFUNCTION WITH LOSS OF PULSE. CODE CALLED. PILOT LINE WAS CUT DURING EXTUBATION AND REINTUBATION. POST PROCEDURE EXAMINATION OF THE BALLOON SHOWED BALLOON PARTIALLY INFLATED. UTILIZING NEEDLE AND SYRINGE STAFF UNABLE TO INFLATE CUFF. PRESSURE TO CUFF ON THE OUTSIDE OF THE CUFF DOES NOT CREATE A LEAK. UNABLE TO TEST PILOT LINE OR INJECTION PORT.

    Description of Event or Problem · 0

    PATIENT WAS SAT UP IN BED FOR A CHEST X-RAY. ET TUBE HAD BEEN IN PLACE SINCE (B)(6) 2025. SUDDEN CHANGE IN OXYGENATION AND VENTILATION NOTED. OBVIOUS CUFF LEAK. RN AND RT INJECTED 3 CC OF AIR WITH IMPROVEMENT AND THEN RAPID SOFTENING OF THE PILOT BALLOON. RECURRENCE OF OBVIOUS CUFF LEAK. UNABLE TO MAINTAIN CUFF PRESSURE. TUBE EMERGENTLY REPLACED. AFTER REINTUBATION, CARDIAC DYSFUNCTION WITH LOSS OF PULSE. CODE CALLED. PILOT LINE WAS CUT DURING EXTUBATION AND REINTUBATION. POST PROCEDURE EXAMINATION OF THE BALLOON SHOWED BALLOON PARTIALLY INFLATED. UTILIZING NEEDLE AND SYRINGE STAFF UNABLE TO INFLATE CUFF. PRESSURE TO CUFF ON THE OUTSIDE OF THE CUFF DOES NOT CREATE A LEAK. UNABLE TO TEST PILOT LINE OR INJECTION PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425135 PARKER ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.0MM BTR PARKER MEDICAL H-PFHV-70 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Death