MAUDE Adverse Event Report: PASSY-MUIR INC. PASSY-MUIR LOW-PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE; TRACHEOSTOMY SPEAKING VALVE

Model Number	PMV 2001
Medical Device Problem Codes	Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Asphyxia (1851)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event did not involve a malfunction of the passy-muir valve.This event was caused by a series of use errors.The user did not respond appropriately to the ventilator disconnect alarm.The user failed to follow the manufacturer's instructions stating that the tracheostomy cuff must be completely deflated when the passy-muir valve is placed.The cuff was not deflated until the rt responded to the event.The user failed to post the warning labels (packaged with each passy-muir valve) on the tracheostomy tube cuff pilot line, or anywhere within the proximity of the patient.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 patient chart.
Event or Problem Description
User facility reported: rn states vent was alarming.Upon entering the room, the ventilator circuit was disconnected.Rn states that the patient was asking for the passy muir valve to be placed on; however, after investigation the patient was telling the rn that the vent had become disconnected.Rn states that she placed the passy muir valve on, (when asked if she deflated the trach cuff, she stated no), rn states that vent continued to alarm.She found charge rn and informed her of the patient with difficulty breathing.The patient was unresponsive, pulseless and blue.The rn initiated chest compressions and a code blue was called.Patient became responsive shortly thereafter.Respiratory found that the trach cuff was still inflated.The rt removed 10ml syringe from within bag hanging from cough assist machine.The patient was suctioned and placed on humidified trach collar (htc) 90%, patient able to vocalize with passy muir valve.Doctor states patient had ekg changes, patient was transported to the icu.

• Brand Name: PASSY-MUIR LOW-PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE
• Common Device Name: TRACHEOSTOMY SPEAKING VALVE
• Manufacturer (Section D): PASSY-MUIR INC.; pmb 273; 4521 campus drive; irvine CA 92612
• MDR Report Key: 7143889
• Report Number: 2024841-2017-00001
• Device Sequence Number: 11048980
• Product Code: JOH
• UDI-Device Identifier: 10859760005148
• UDI-Public: 10859760005148
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K962714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/27/2017

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: Nurse
• Device Model Number: PMV 2001
• Device Catalogue Number: PMV 2001
• Device Lot Number: 001-061603D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/22/2017
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 91