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

Model Number 1009-9012-000

Device Problem Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

No patient information provided to date after calls to customer 06/17/21, 06/18/21, and 06/22/21.A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The o2 knob was replaced and the gas delivery system was calibrated to resolve the reported issue.

Event Description

The hospital reported a malfunction that could cause a hypoxic mixture in the patient circuit.There was no report of patient injury.

• Brand Name: AESPIRE 7900
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 12075745
• MDR Text Key: 261488239
• Report Number: 2112667-2021-01628
• 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
• Report Date: 06/28/2021

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
• Device Model Number: 1009-9012-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2012
• 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