MAUDE Adverse Event Report: UNKNOWN; CIRCULATOR, BREATHING-CIRCUIT

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Code Available (3191)

Event Date 06/04/2016

Event Type  malfunction  

Event Description

At 0750 the rt notified staff that a red fluid was in the tubing coming from the cpap ventilator.

• Type of Device: CIRCULATOR, BREATHING-CIRCUIT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5750581
• MDR Text Key: 48225581
• Report Number: 5750581
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/15/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1