MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH FABIUS GS; ANESTHESIA UNITS

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

It was reported that the ventilator failed during the case and the patient was bagged for the remainder without any problems.No injury reported.

Manufacturer Narrative

The investigation was started but is not yet concluded.The investigation results will be reported in the follow up report.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; moislinger allee 53-55; lubeck 2354 2; GM 23542
• Manufacturer Contact: frank clanzett ; moislinger allee 53-55; lubeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 4734803
• MDR Text Key: 16559028
• Report Number: 9611500-2015-00050
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2015
• Initial Date FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1