Passy-Muir PMV 007Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10859760005025), received between Jul 23, 2019 and Jul 23, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  NON-FATALITY REPORT: USER FACILITY COMBINED FOUR INCIDENTS TOGETHER WITH THE SAME NARRATIVE. THE MANUFACTURER IS REQUIRED TO FILE FOUR SEPARATE REPORTS (MFR REPORT #2024841-2019-00001, 2024841-2019-00002, 2024841-2019-00003, AND 2024841-2019-00004) IN RESPONSE TO THE COMBINED NARRATIVE. USER FACILITY REPORTED: "4 X SEPARATE INCIDENTS IN CRITICAL CARE OVER 6-8 MONTH PERIOD WHERE TRACHEOSTOMY CUFF INFLATION WHILE PMV IN SITU IN VENTILATOR DEPENDENT PATIENTS HAS LEAD TO PATIENT DETERIORATION AND PERI-ARREST INCIDENT BEFORE THIS ERROR HAS BEEN RECOGNISED. PATIENT REQUIRED MANUAL BAG VENTILATION AND/OR PERI ARREST MANAGEMENT TO PREVENT CARDIAC ARREST AND/OR DEATH. ALL PATIENTS RECOVERED FULLY. ALL INCIDENTS INVESTIGATED."

  Patient problems: Asphyxia

  MAUDE report 8819506 ↗
• InjuryJul 23, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  NON-FATALITY REPORT: USER FACILITY COMBINED FOUR INCIDENTS TOGETHER WITH THE SAME NARRATIVE. THE MANUFACTURER IS REQUIRED TO FILE FOUR SEPARATE REPORTS (MFR REPORT #2024841-2019-00001, 2024841-2019-00002, 2024841-2019-00003, AND 2024841-2019-00004) IN RESPONSE TO THE COMBINED NARRATIVE. USER FACILITY REPORTED: "4 X SEPARATE INCIDENTS IN CRITICAL CARE OVER 6-8 MONTH PERIOD WHERE TRACHEOSTOMY CUFF INFLATION WHILE PMV IN SITU IN VENTILATOR DEPENDENT PATIENTS HAS LEAD TO PATIENT DETERIORATION AND PERI-ARREST INCIDENT BEFORE THIS ERROR HAS BEEN RECOGNISED. PATIENT REQUIRED MANUAL BAG VENTILATION AND/OR PERI ARREST MANAGEMENT TO PREVENT CARDIAC ARREST AND/OR DEATH. ALL PATIENTS RECOVERED FULLY. ALL INCIDENTS INVESTIGATED."

  Patient problems: Asphyxia

  MAUDE report 8819488 ↗
• InjuryJul 23, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  NON-FATALITY REPORT: USER FACILITY COMBINED FOUR INCIDENTS TOGETHER WITH THE SAME NARRATIVE. THE MANUFACTURER IS REQUIRED TO FILE FOUR SEPARATE REPORTS (MFR REPORT #2024841-2019-00001, 2024841-2019-00002, 2024841-2019-00003, AND 2024841-2019-00004) IN RESPONSE TO THE COMBINED NARRATIVE. USER FACILITY REPORTED: "4 X SEPARATE INCIDENTS IN CRITICAL CARE OVER 6-8 MONTH PERIOD WHERE TRACHEOSTOMY CUFF INFLATION WHILE PMV IN SITU IN VENTILATOR DEPENDENT PATIENTS HAS LEAD TO PATIENT DETERIORATION AND PERI-ARREST INCIDENT BEFORE THIS ERROR HAS BEEN RECOGNISED. PATIENT REQUIRED MANUAL BAG VENTILATION AND/OR PERI ARREST MANAGEMENT TO PREVENT CARDIAC ARREST AND/OR DEATH. ALL PATIENTS RECOVERED FULLY. ALL INCIDENTS INVESTIGATED.".

  Patient problems: Asphyxia

  MAUDE report 8819487 ↗
• InjuryJul 23, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  NON-FATALITY REPORT: USER FACILITY COMBINED FOUR INCIDENTS TOGETHER WITH THE SAME NARRATIVE. THE MANUFACTURER IS REQUIRED TO FILE FOUR SEPARATE REPORTS (MFR REPORT #2024841-2019-00001, 2024841-2019-00002, 2024841-2019-00003, AND 2024841-2019-00004) IN RESPONSE TO THE COMBINED NARRATIVE. USER FACILITY REPORTED: "4 X SEPARATE INCIDENTS IN CRITICAL CARE OVER 6-8 MONTH PERIOD WHERE TRACHEOSTOMY CUFF INFLATION WHILE PMV IN SITU IN VENTILATOR DEPENDENT PATIENTS HAS LEAD TO PATIENT DETERIORATION AND PERI-ARREST INCIDENT BEFORE THIS ERROR HAS BEEN RECOGNISED. PATIENT REQUIRED MANUAL BAG VENTILATION AND/OR PERI ARREST MANAGEMENT TO PREVENT CARDIAC ARREST AND/OR DEATH. ALL PATIENTS RECOVERED FULLY. ALL INCIDENTS INVESTIGATED."

  Patient problems: Asphyxia

  MAUDE report 8819479 ↗