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

Device Problem Loss of Threshold (1633)

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.

Event Description

The ge healthcare repair depot reported that the physical defect of the compact block would prevent use for any kind of operation.There was no report of patient involvement.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The compact block was replaced to resolve the reported issue.

• Brand Name: ADU
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki, FIN-0 0510; FI FIN-00510
• MDR Report Key: 7231587
• MDR Text Key: 98740780
• Report Number: 9610105-2018-00005
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• 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: 02/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1