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

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2016

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment.Inspection of the equipment noted the audible alarms were not functioning.The audio amplifier board was reseated and the audible alarms functioned.Patient information currently unavailable.

Event Description

The hospital reported that, during a case, the ventilator failed.There was no reported patient injury.The hospital biomed noted that the absorber canister was cracked, creating a leak condition.The biomed replaced the canister.

• Brand Name: ADU
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki 510 ; FI 510
• Manufacturer (Section G): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki 510 ; FI 510
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010
• MDR Report Key: 5767924
• MDR Text Key: 48714801
• Report Number: 9610105-2016-00032
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050676
• 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
• Report Date: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2003
• 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