MAUDE Adverse Event Report: DATEX-OHMEDA, INC AVANCE; ANESTHESIA MACHINE

Device Problem No Flow (2991)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

The hospital reportedly noted during a preuse checkout of the equipment that oxygen was not flowing out the auxiliary oxygen flowmeter.There was no reported patient involvement.

Manufacturer Narrative

This malfunction was determined to be reportable as this same malfunction has previously contributed to a serious injury within the last two years.Reference mdr 2112667-2014-00077.

• Brand Name: AVANCE
• Type of Device: ANESTHESIA MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 4852673
• MDR Text Key: 21846348
• Report Number: 2112667-2015-00015
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/30/2015

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: 05/21/2015
• Initial Date FDA Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1