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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 07/08/2015

Event Type  Injury  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

It ws reported that the pt suffered a bilateral pneumothorax.No further info has been released to ge healthcare.

Manufacturer Narrative

The hospital reported that, at the start of the case,prior to surgery, the machine would not deliver a breath.The case crna reported she switched to an ambu bag connected to a transport oxygen cylinder and ventilated the patient.The case was cancelled, and the patient was transferred to the recovery room.An x-ray was taken and a bilateral pneumothorax was noted.Following the case, the anesthesia technician reportedly performed a checkout, and the equipment was functioning to specification.A ge healthcare service representative performed a checkout of the equipment and noted the air pressure sensor failed high at 4.34 (spec is 4.02), and one of the auxiliary power outlets was not functional, neither of which are related to the reported complaint.

• Brand Name: ADU
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; fin kuortaneenkatu 2; helsinki 510 ; FI 510
• Manufacturer (Section G): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki, FIN 510; FI FIN 510
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 5006640
• MDR Text Key: 23329661
• Report Number: 9610105-2015-00009
• 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: Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2003
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 79