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

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.The system had the original batteries from the installation on 08/31/2012.Per the avance technical reference manual: "although replacement of the backup batteries is recommended at the end of 4 years, batteries that pass the capacity test can be considered viable for battery backup of the system for up to 6 years at the discretion of the hospital." device evaluation anticipated, but not yet begun.

Event Description

The hospital reported the unit lost power during a power outage.There was no reported patient injury.

Manufacturer Narrative

Multiple attempts were made to obtain further information from the customer contact.To do, no further information is available.

• Brand Name: AVANCE
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL
• MDR Report Key: 6572559
• MDR Text Key: 75356183
• Report Number: 2112667-2017-00894
• 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 faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1