MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY ADU; ANESTHESIA GAS MACHINE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.Date of manufacture was not available at the time of filing.A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The customer decided to retire the unit from service.

Event Description

The hospital reported that the system was not coming on.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received stating that only the patient monitor screen was blank.There was no power loss to the system.Mechanical ventilation was not lost.This was not a reportable malfunction.Additional information was received stating that only the patient monitor screen was blank.There was no power loss to the system.Mechanical ventilation was not lost.This was not a reportable malfunction.

• Brand Name: ADU
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki ; FI
• MDR Report Key: 7648229
• MDR Text Key: 112868224
• Report Number: 9610105-2018-00028
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K050676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• 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: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1