MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE

Model Number 1009-9000-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 02/24/2020

Event Type  Death  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is complete.There was no allegation of the device malfunctioning and the customer wanted ge to check out the device.The ge representative went onsite and performed operational checks and found the device to perform to specifications.

Event Description

The hospital reported that during a procedure, the patient passed away.There was no report or allegation of a system malfunction.

Manufacturer Narrative

Additional information was received that the customer stated the device did not cause the patient death.The device performed to specifications and did not cause or contribute to the death.Additional information was received that the customer stated the device did not cause the patient death.The device performed to specifications and did not cause or contribute to the death.

• Brand Name: AESPIRE 7100
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 9880904
• MDR Text Key: 184951508
• Report Number: 2112667-2020-00951
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• 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,Followup
• Report Date: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1009-9000-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2010
• 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
• Patient Outcome(s): Death
• Patient Age: 7 YR