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

Device Problem Inaccurate Delivery (2339)

Patient Problem Insufficient Information (4580)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Unique identifier: (b)(4).Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported an over delivery of tidal volume.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that there was no over delivery, only a monitoring issue.Further, a ge healthcare service representative performed a checkout of the system but did not confirm the reported issue.H3 other text : additional information was received that there was no over delivery, only a monitoring issue.Further, a ge healthcare service representative performed a checkout of the system but did not confirm the reported issue.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system but did not confirm the reported issue.

• 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: 12119161
• MDR Text Key: 262421569
• Report Number: 2112667-2021-01680
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/05/2021
• Supplement Dates Manufacturer Received: 07/21/2021; 07/26/2021
• Supplement Dates FDA Received: 07/19/2021; 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1