MAUDE Adverse Event Report: WESTMED MRI TRANSPORT CIRCUIT; PEEP VALVE, VENT CIRCUIT + PATIENT VALVE

Model Number 9317

Device Problem Misconnection (1399)

Patient Problems Atrial Fibrillation (1729); Low Oxygen Saturation (2477)

Event Date 01/23/2014

Event Type  Injury  

Event Description

The design of the transport breathing vent circuit allows the connector to be hooked up incorrectly.Pt was placed at portable ventilator; pt's sats were noted to desat to 50s briefly pt went into rapid afib when sats dropped, but returned to baseline with improved sats after being placed on standard ventilator.

• Brand Name: MRI TRANSPORT CIRCUIT
• Type of Device: PEEP VALVE, VENT CIRCUIT + PATIENT VALVE
• Manufacturer (Section D): WESTMED; 5580 s. nogales highway; tucson AZ 85706
• MDR Report Key: 3628149
• MDR Text Key: 3990409
• Report Number: MW5034428
• Device Sequence Number: 1
• Product Code: BYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9317
• Device Lot Number: 08272013401
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2014
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 95 YR
• Patient Weight: 55