MAUDE Adverse Event Report: PASSY-MUIR INC. PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 007; PASSY-MUIR VALVE

Model Number	PMV 007
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Asphyxia (1851)
Date of Event	05/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event did not involve malfunction of the passy-muir valve.The user failed to follow manufacturer's instructions stating that the tracheostomy cuff must be completely deflated when the passy-muir valve is placed.As the manufacturer of the passy-muir valve, we take special care to package every valve with a comprehensive clinical instruction booklet and caution labels.The caution labels are brightly colored and designed to be placed on the tracheostomy tube pilot line where the cuff is inflated and deflated.
Event or Problem Description
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.".
Additional Manufacturer Narrative
This event did not involve malfunction of the passy-muir valve.The user failed to follow manufacturer's instructions stating that the tracheostomy cuff must be completely deflated when the passy-muir valve is placed.As the manufacturer of the passy-muir valve, we take special care to package every valve with a comprehensive clinical instruction booklet and caution labels.The caution labels are brightly colored and designed to be placed on the tracheostomy tube pilot line where the cuff is inflated and deflated.Disclaimer: submission of this report does not constitute an admission that any medical personnel, user facility, distributor, manufacturer, or device caused or contributed to the event.On (b)(6) 2019, the date of event ((b)(6) 2019) was obtained by passy-muir from the user facility.- attachment: [submittal cover letter mdr 2024841-2019-00004.Pdf].
Event or Problem Description
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.".

• Brand Name: PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 007
• Common Device Name: PASSY-MUIR VALVE
• Manufacturer (Section D): PASSY-MUIR INC.; pmb 273, 4521 campus drive; irvine CA 92612 2612
• MDR Report Key: 8819487
• Report Number: 2024841-2019-00004
• Device Sequence Number: 18913958
• Product Code: JOH
• UDI-Device Identifier: 10859760005025
• UDI-Public: 10859760005025
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K903699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: PMV 007
• Device Catalogue Number: PMV 007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening