MAUDE Adverse Event Report: SMITHS MEDICAL 7 PORTEX BIVONA TTS

Model Number UNAVAILABLE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Distress (2329)

Event Date 10/21/2016

Event Type  malfunction  

Event Description

Pt found in distress with trach cuff and not returning volumes.Trach changed to 8sct.Saturation went back to the 90s and pt no longer in distress.No harm to pt.

• Brand Name: 7 PORTEX BIVONA TTS
• Type of Device: 7 PORTEX BIVONA TTS
• Manufacturer (Section D): SMITHS MEDICAL; dublin PA 43017
• MDR Report Key: 6099216
• MDR Text Key: 60079161
• Report Number: MW5065985
• Device Sequence Number: 1
• Product Code: BTO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 61