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

Device Problems Air Leak (1008); Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 12/30/2016

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Date of device manufacture year is 2002.The month of manufacture was december.Ge healthcare¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that, unit failed the start-up test with the message: leak in o2/air is detected.There was no reported patient involvement.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system but was unable to reproduce the reported issue.The customer had already replaced the 3rd party patient circuit.

Manufacturer Narrative

Additional information was received from the fe that there was no malfunction of the ge healthcare equipment.A third party patient circuit was leaking at a 300 ml/min rate.This is not a reportable malfunction.

• Brand Name: ADU
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki ; FI
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 6282548
• MDR Text Key: 66158194
• Report Number: 9610105-2017-00012
• 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,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2016
• 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