MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE

Model Number 1009-9012-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Sudden Cardiac Death (2510)

Event Date 06/05/2019

Event Type  Death  

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.Patient identifier: not available.Patient weight: it was reported the patient was between 80 to 100 kilograms.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

Ge healthcare was notified by the hospital that during a urological surgery, prior to being ventilated, the patient experienced a cardio respiratory arrest after which the patient was put on manual ventilation.The patient subsequently died.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and found no issues with the operation of the unit.An investigation was opened per the customer's request following a patient death during surgery.Analysis of the system logs and analysis of complaint data found there were no malfunctions or events that could contribute to a patient's death.The physician reiterates that the event has no connection with a failure in the device.The root cause of the reported event is undetermined.

• Brand Name: AESPIRE 7900
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 8786898
• MDR Text Key: 150954033
• Report Number: 2112667-2019-00239
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K050626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1009-9012-000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/12/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 43 YR