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

Device Problems Loss of Power (1475); Device Operates Differently Than Expected (2913)

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

Event Date 07/20/2016

Event Type  malfunction  

Event Description

Biomed was informed by anesthesia staff that the ge avance anesthesia machine will go off-line and reboot when the equipment tower draw is closed hard.Bio-med conducted a test on 17 avance machines and 15 out of 17 stopped working and rebooted programming when the storage draw is closed harder than normal.Manufacturer response for avance anesthesia machine, avance anesthesia machine (per site reporter): bio-medical has spoken with ge healthcare and they are aware of the problem, but do not have a correction of issue at this time.

• Brand Name: AVANCE ANESTHESIA MACHINE
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3000 n grandview blvd; waukesha WI 53188
• MDR Report Key: 5846322
• MDR Text Key: 51152815
• Report Number: 5846322
• Device Sequence Number: 1
• Product Code: BSZ
• 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: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: APKT00848
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES