BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARKER

    MDR report key: 20858113 · Received December 5, 2024

    Report

    Report Number
    3000219639-2024-00130
    Event Type
    Death
    Date Received
    December 5, 2024
    Date of Event
    September 17, 2024
    Report Date
    December 5, 2024
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    UDI-DI
    00607411952746
    PMA / PMN Number
    K984528
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): ENDOTRACHEAL 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 05 DEC 2024 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.

    Additional Manufacturer Narrative · 0

    H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): ENDOTRACHEAL 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 05 DEC 2024 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 1 ADDITIONAL COMPLAINTS WERE IDENTIFIED RELATED TO THIS ISSUE HOWEVER NO TREND WAS OBSERVED. THE LOT NUMBER WAS 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.

    Description of Event or Problem · 0

    IT WAS STATED BY CUSTOMER THAT "WHILE INTUBATING THE PATIENT, THE INFLATING TUBE WAS DISLODGED AND THE CUFF ATROPHIED. THE PATIENT LATER DIED. THE HOSPITAL WAS OF THE OPINION THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE DISLODGED INFLATING TUBE AND THE DEATH. WE DO NOT KNOW THE CAUSE-AND-EFFECT RELATIONSHIP".

    Description of Event or Problem · 0

    IT WAS STATED BY CUSTOMER THAT "WHILE INTUBATING THE PATIENT, THE INFLATING TUBE WAS DISLODGED AND THE CUFF ATROPHIED.THE PATIENT LATER DIED. THE HOSPITAL WAS OF THE OPINION THAT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE DISLODGED INFLATING TUBE AND THE DEATH. WE DO NOT KNOW THE CAUSE-AND-EFFECT RELATIONSHIP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543597 PARKER ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.5MM BTR PARKER MEDICAL H-PFHV-75 UNKNOWN 00607411952746

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death