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	Pneumothorax (2012)
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.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.The caution labels are brightly colored and 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.This product is brightly colored and marked passy-muir.
Event or Problem Description
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.

• 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
• MDR Report Key: 11282660
• Report Number: 2024841-2021-00001
• Device Sequence Number: 4371643
• Product Code: JOH
• UDI-Device Identifier: 10859760005148
• UDI-Public: 10859760005148
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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 faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/04/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention