Passy-Muir PMV 2001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10859760005148), received between Nov 13, 2017 and Apr 18, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2023Use of Device Problem; Use of Device Problem

  PATIENT HAD TRACHEOSTOMY AND HAD CUFF INFLATED DURING PROCEDURE IN OR. THE PATIENT WAS TRANSFERRED TO AN ICU POST-OPERATIVELY. THE CUFF WAS STILL INFLATED. THE NURSE CARING FOR THE PATIENT ATTACHED THE PASSY-MUIR VALVE TO THE TRACH WHILE THE CUFF WAS INFLATED TO ALLOW THE PATIENT TO SPEAK. THE PATIENT BECAME BRADYCARDIAC, DESATURATED EVENTUALLY PEA ARRESTED. A CODE WAS CALLED, AND IT WAS REALIZED DURING THE CODE THE CUFF WAS INFLATED AND ATTACHED. THE VALVE WAS REMOVED ALLOWING FOR AN UNOBSTRUCTED AIRWAY, AND THE PATIENT RESUSCITATED. THE PATIENT REMAINS IN THE ICU.

  Patient problems: Bradycardia

  MAUDE report 16765931 ↗
• InjuryJun 3, 2022Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  PATIENT TRANSFERRED FROM HIGHER LEVEL OF ACUTE CARE TO LOWER LEVEL. PRIOR TO TRANSFER, PATIENT USING VALVE ((B)(4)) WHEN OFF VENTILATOR. HOWEVER, AFTER TRANSFER, REPORT OF INCREASED SECRETIONS. PLACED BACK ON VENT OVERNIGHT. AT 8 AM ON (B)(6) 2022 WAS SUCTIONED AND TAKEN OFF VENT. PLACED ON TRACH COLLAR WITH CUFF LEFT INFLATED DUE TO SECRETIONS. CARE PARTNER ENTERED ROOM TO ASSIST WITH FEEDING, PLACED THE PASSY-MUIR VALVE WITHOUT ASSESSING CUFF STATUS. PATIENT EXHIBITED SIGNIFICANT DESATURATIONS AND BRADYCARDIA. MEDICAL INTERVENTION WAS REQUIRED. TEAM REMOVED VALVE AND PLACED PATIENT BACK ON VENTILATOR. HOSPITAL EVALUATED THE SITUATION AND FILED A SAFETY INTELLIGENCE REPORT WITH THE FOLLOWING FINDINGS: CARE PARTNER FROM HOME PRACTICED OUTSIDE OF SCOPE AS THEY ARE NOT ALLOWED TO PLACE SPEAKING VALVES WITHIN THE HOSPITAL SETTING; SIGNAGE RELATED TO VALVE USE AND CUFF DEFLATION DID NOT ACCOMPANY PATIENT FROM HIGHER LEVEL OF CARE; WARNING LABEL WAS NOT IN PLACE (PRIOR USAGE UNKNOWN). HOSPITAL HAS IMPLEMENTED: RT TO HAVE RESPONSIBILITY FOR SIGNAGE AND ASCERTAIN THAT IT IS POSTED IN ROOMS FOLLOWING TRANSFERS, SPEECH-LANGUAGE PATHOLOGIST TO BE CONSULTED IF A PATIENT IS ADMITTED WITH A TRA

  Patient problems: Bradycardia

  MAUDE report 14598200 ↗
• InjuryFeb 4, 2021Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  AS REPORTED BY DOCTOR: AT THE END OF A BRIEF PROCEDURE, A CUFFED TRACH TUBE WAS REPLACED IN THE ESTABLISHED TRACHEOTOMY TRACT AND THE PATIENT WAS VENTILATED THROUGH IT. AFTER THE PATIENT WAS BREATHING SPONTANEOUSLY, BUT BEFORE THE ABILITY TO COMMUNICATE EFFECTIVELY RETURNED, THE ASSEMBLY WHICH THE PATIENT HAD WORN INTO THE OR, CONSISTING OF THE (PURPLE) PM VALVE AND A MEANS OF DELIVERING OXYGEN, WAS REPLACED. NOBODY REALIZED THAT EITHER THE VALVE SHOULD HAVE BEEN REMOVED OR THE CUFF SHOULD HAVE BEEN DEFLATED. FAIRLY SOON, THE PATIENT'S RESPIRATORY STATUS DECLINED AND PENEUMOTHORAX WAS IDENTIFIED QUICKLY.

  Patient problems: Pneumothorax

  MAUDE report 11282660 ↗
• InjuryDec 22, 2017Inadequate or Insufficient Training; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Inadequate or Insufficient Training; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED: RN STATES VENT WAS ALARMING. UPON ENTERING THE ROOM, THE VENTILATOR CIRCUIT WAS DISCONNECTED. RN STATES THAT THE PATIENT WAS ASKING FOR THE PASSY MUIR VALVE TO BE PLACED ON; HOWEVER, AFTER INVESTIGATION THE PATIENT WAS TELLING THE RN THAT THE VENT HAD BECOME DISCONNECTED. RN STATES THAT SHE PLACED THE PASSY MUIR VALVE ON, (WHEN ASKED IF SHE DEFLATED THE TRACH CUFF, SHE STATED NO), RN STATES THAT VENT CONTINUED TO ALARM. SHE FOUND CHARGE RN AND INFORMED HER OF THE PATIENT WITH DIFFICULTY BREATHING. THE PATIENT WAS UNRESPONSIVE, PULSELESS AND BLUE. THE RN INITIATED CHEST COMPRESSIONS AND A CODE BLUE WAS CALLED. PATIENT BECAME RESPONSIVE SHORTLY THEREAFTER. RESPIRATORY FOUND THAT THE TRACH CUFF WAS STILL INFLATED. THE RT REMOVED 10ML SYRINGE FROM WITHIN BAG HANGING FROM COUGH ASSIST MACHINE. THE PATIENT WAS SUCTIONED AND PLACED ON HUMIDIFIED TRACH COLLAR (HTC) 90%, PATIENT ABLE TO VOCALIZE WITH PASSY MUIR VALVE. DOCTOR STATES PATIENT HAD EKG CHANGES, PATIENT WAS TRANSPORTED TO THE ICU.

  Patient problems: Asphyxia

  MAUDE report 7143889 ↗
• InjuryNov 13, 2017Device Alarm System; Disconnection

  RN STATES VENT WAS ALARMING. UPON ENTERING THE ROOM, THE VENTILATOR CIRCUIT WAS DISCONNECTED. RN STATES THAT THE PATIENT WAS ASKING FOR THE PASSY MUIR VALVE TO BE PLACED ON; HOWEVER, AFTER INVESTIGATION THE PATIENT WAS TELLING THE RN THAT THE VENT HAD BECOME DISCONNECTED. RN STATES THAT SHE PLACED THE PASSY MUIR VALVE ON, (WHEN ASKED IF SHE DEFLATED THE TRACH CUFF, SHE STATED NO), RN STATES THAT VENT CONTINUED TO ALARM. SHE FOUND CHARGE RN AND INFORMED HER OF THE PATIENT WITH DIFFICULTY BREATHING. THE PATIENT WAS UNRESPONSIVE, PULSELESS AND BLUE. THE RN INITIATED CHEST COMPRESSIONS AND A CODE BLUE WAS CALLED. PATIENT BECAME RESPONSIVE SHORTLY THEREAFTER. RESPIRATORY FOUND THAT THE TRACH CUFF WAS STILL INFLATED. THE RT REMOVED 10ML SYRINGE FROM WITHIN BAG HANGING FROM COUGH ASSIST MACHINE. THE PATIENT WAS SUCTIONED AND PLACED ON HUMIDIFIED TRACH COLLAR (HTC) 90%, PATIENT ABLE TO VOCALIZE WITH PASSY MUIR VALVE. DOCTOR STATES PATIENT HAD EKG CHANGES, PATIENT WAS TRANSPORTED TO THE ICU.

  Patient problems: Dyspnea; Loss Of Pulse; No Code Available; Non specific EKG/ECG Changes

  MAUDE report 7024164 ↗