MAUDE Adverse Event Report: DATEX-OHMEDA, INC AESTIVA 3000; ANESTHESIA GAS MACHINE

Device Problem Loss of Power (1475)

Patient Problem Brain Injury (2219)

Event Date 03/05/2013

Event Type  Injury  

Event Description

Ge healthcare has been notified of a legal claim in which it is alleged that the mechanical ventilator failed and the patient incurred brain damage.

Manufacturer Narrative

Ge healthcare (gehc) was notified of the initial complaint on (b)(6) 2013.At the time, the customer reported the system would not properly boot up.There was no reported patient injury.A gehc service representative performed a checkout of the equipment, and replaced the cpu.The part was subsequently discarded.In july 2015, gehc was notified via a legal complaint that the patient was inadequately oxygenated during a surgical procedure, causing permanent brain damage.Due to open litigation, customer response to all investigation questions were answered, "undetermined pending outcome of ongoing litigation".

• Brand Name: AESTIVA 3000
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL 60010-3076 ; 8472774719
• MDR Report Key: 4954209
• MDR Text Key: 6633072
• Report Number: 2112667-2015-00054
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2000
• 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): Disability
• Patient Age: 62 YR
• Patient Weight: 72