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

Device Problems Tidal Volume Fluctuations (1634); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.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 the unit had inaccurate tidal volume.Patient use is currently unknown.

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.The ge healthcare service representative performed a checkout of the equipment and confirmed the mylar flap of the expiratory flow sensor was stuck to the top of the flow sensor housing.The flow sensor was replaced, and the unit was returned to service.

• Brand Name: AESPIRE 7100
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 6694368
• MDR Text Key: 79398111
• Report Number: 2112667-2017-01256
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K000706
• 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: 07/12/2017

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: 06/08/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 06/08/2017
• Supplement Dates FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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