MAUDE Adverse Event Report: PASSY-MUIR INC. PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 2001; TRACHEOSTOMY SPEAKING VALVE

Model Number	PMV 2001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.
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.The user appears to have applied a medical device without sufficient knowledge or understanding of the medical device.As the manufacturer of the passy-muir valve, we take special care to package every valve with a comprehensive clinical instruction booklet, patient handbook, and caution labels that warn "tracheostomy tube cuff must be completely deflated before placing the pmv" and that "the patient will be unable to breathe if cuff is not completely deflated".The caution labels are designed to be placed on the tracheostomy tube pilot line where the cuff is inflated and deflated, as well as at the bedside and in the patient chart.The caution labels are brightly colored to bring attention to the caution of cuff deflation and ensure proper patient monitoring with passy-muir valve in place.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.

• Brand Name: PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE PMV 2001
• Common Device Name: TRACHEOSTOMY SPEAKING VALVE
• Manufacturer (Section D): PASSY-MUIR INC.; 4521 campus drive, pmb 273; irvine CA 92612
• Manufacturer Contact: cameron jolly ; 4521 campus drive, pmb 273; irvine, CA 92612 ; 9498338255
• MDR Report Key: 16765931
• Report Number: 2024841-2023-00001
• Device Sequence Number: 2959456
• Product Code: JOH
• UDI-Device Identifier: 10859760005148
• UDI-Public: 10859760005148
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K962714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/18/2023

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: Health Professional
• Device Model Number: PMV 2001
• Device Catalogue Number: PMV 2001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White