MAUDE Adverse Event Report: DRAEGER MEDICAL; GAS-MACHINE, ANESTHESIA

Model Number FABIUS MRI

Device Problem Ventilation Problem in Device Environment (3027)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/30/2018

Event Type  malfunction  

Event Description

Upon placing patient on mri fabius ventilator in mri, the ventilator stated oxygen sensor.The patient required manual ventilation.

• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DRAEGER MEDICAL; 3135 quarry rd; telford PA 18969
• MDR Report Key: 8280847
• MDR Text Key: 134231648
• Report Number: 8280847
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FABIUS MRI
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA
• Patient Weight: 113