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 Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	04/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event did not involve malfunction of the passy-muir valve.The user practiced outside of their scope and failed to follow manufacturer's instructions stating that the 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 not be able 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 the passy-muir valve in place.
Event or Problem Description
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 tracheostomy, warning labels to be used on all patients, signage to be placed at head of bed.

• 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: 4521 campus drive; pmb 273; irvine, CA 92612
• MDR Report Key: 14598200
• Report Number: 2024841-2022-00001
• Device Sequence Number: 14905688
• Product Code: JOH
• UDI-Device Identifier: 10859760005148
• UDI-Public: 10859760005148
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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 2001
• Device Catalogue Number: PMV 2001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male