MAUDE Adverse Event Report: PASSY-MUIR, INC. PASSY-MUIR; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	PMV 2001
Health Effect - Clinical Codes	Dyspnea (1816); Non specific EKG/ECG Changes (1817); Loss Of Pulse (2562); No Code Available (3191)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
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
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): PASSY-MUIR, INC.; 17992 mitchell s ste 200; irvine CA 92614
• MDR Report Key: 7024164
• Report Number: 7024164
• Device Sequence Number: 1275772
• Product Code: JOH
• UDI-Device Identifier: 10859760005148
• UDI-Public: (01)10859760005148(10)001-061603D
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/09/2017
• Report Date (Section F): 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Nurse
• Device Model Number: PMV 2001
• Device Catalogue Number: PMV 2001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PORTEX #8 TRACHEOSTOMY WAS BEING USED AND THE CUFF
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 91
• Date Report Sent to FDA: 11/09/2017