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	11/15/2018
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.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.
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 (this mfr report #, 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.".
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 7/25/2019, the date of event (b)(6) 2018) was obtained by passy-muir from the user facility.

• 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 2812
• MDR Report Key: 8819479
• Report Number: 2024841-2019-00001
• Device Sequence Number: 3082048
• 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