MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7100; ANESTHESIA GAS MACHINE

Device Problems Loss of Power (1475); Reset Problem (3019)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.Initial reporter: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare's investigation is ongoing.A follow up-report will be submitted once the investigation has been completed.

Event Description

The hospital reported the unit had a system reset error that caused the unit to shutdown automatically.There is no report of patient involvement.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The control board was replaced and the unit was returned to service.

• Brand Name: AESTIVA 7100
• Type of Device: ANESTHESIA GAS 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: brad wheeler ; 3000 n. grandview blvd., w450; waukesha, WI 53188
• MDR Report Key: 5637384
• MDR Text Key: 44999533
• Report Number: 2112667-2016-00860
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K000706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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