BEUDAMED
    FDA Adverse Event Death Summary report: N

    PASSY MUIR TRACHEOSTOMY & VENTILATOR

    MDR report key: 43330 · Received September 16, 1996

    Report

    Report Number
    2024841-1996-00003
    Event Type
    Death
    Date Received
    September 16, 1996
    Date of Event
    March 26, 1996
    Report Date
    September 16, 1996
    Manufacturer
    PASSY MUIR, INC.
    Product Code
    BTO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON INFO REPORTED BY THE USER FACILITY IN THIS CASE, THERE WAS NO DEVICE MALFUNCTION ON THE PART OF THE SPEAKING VALVE. PT DEATH OCCURRED DUE TO USER ERROR OF THE DEVICE (TRACHEOSTOMY TUBE CUFF WAS INFLATED BY A HEALTH PROFESSIONAL WHILE THE VALVE WAS STILL IN PLACE). AS THE MFR OF THE VALVE, CO TAKES SPECIAL CARE TO PACK EVERY VALVE WITH AN EXTENSIVE INSTRUCTION BOOKLET AND CAUTION LABELS THAT SPECIFICALLY STATE THAT THE TRACHEOSTOMY TUBE CUFF MUST BE DEFLATED WHEN THE VALVE IS IN PLACE. THE CAUTION LABELS ARE DESIGNED TO BE PLACED ON THE TRACHEOSTOMY TUBE AS WELL AS A BEDSIDE OR ON THE PTS' CHART. THIS UNFORTUNATE INCIDENT WAS DUE TO HUMAN ERROR.

    Additional Manufacturer Narrative · 1

    BASED ON INFO REPORTED BY THE USER FACILITY IN THIS CASE, THERE WAS NO DEVICE MALFUNCTION ON THE PART OF THE SPEAKING VALVE. PT DEATH OCCURRED DUE TO ERROR OF THE DEVICE (TRACHEOSTOMY TUBE CUFF WAS INFLATED BY A HEALTH PROFESSIONAL WHILE THE VALVE WAS STILL INPLACE. AS THE MFR OF THE VALVE, CO TAKES SPECIAL CARE TO PACK EVERY VALVE WITH AN EXTENSIVE INSTRUCTION BOOKLET AND CAUTION LABELS THAT SPECIFICALLY STAT THAT THE TRACHEOSTOMY TUBE CUFF MUST BE DEFLATED WHEN THE VALVE IS IN PLACE. THE CAUTION LABELS ARE DESIGNED TO BE PLACED ON THE TRACHEOSTOMY, TUBE AS WELL AS AT BEDSIDE OR ON THE PTS' CHART. THIS UNFORTUNATE INCIDENT WA DUE TO HUMAN ERROR.

    Description of Event or Problem · 1

    MEDICAL EXAMINER CALLED AND REPORTED AN ACCIDENTAL DEATH DUE TO ASPHYXIATION. HIS CUFF OF THE PT'S TRACHEOSTOMY TUBE WHILE THE PT WAS WEARING THE SPEAKING VALVE. DEATH OCCURRED DUE TO HUMAN ERROR PER MEDICAL EXAMINER AND HSP CONTACT. MEDICAL EXAMINER NOTIFIED CO ON 9/17/96.

    Description of Event or Problem · 1

    MEDICAL EXAMINER CALLED AND REPORTED AN ACCIDENTAL DEATH DUE TO ASPHYXIATION. HIS REPORT INDICATED A STAFF MEMBER INFLATED THE CUFF OF THE PT'S TRACHEOSTOMY TUBE WHILE THE PT WAS WEARING THE SPEAKING VALVE. DEATH OCCURRED DUE TO HUMAN ERROR PER MEDICAL EXAMINER AND HOSP CONTACT. MEDICAL EXAMINER NOTIFIED CO ON 9/17/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSY MUIR TRACHEOSTOMY & VENTILATOR SPEAKING VALVE BTO PASSY MUIR, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death CUFFED TRACHEOSTOMY TUBE