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

Device Problem Tidal Volume Fluctuations (1634)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2016

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.A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.It was discovered the mylar flap of the flow sensor was stuck to the top of the flow sensor housing.The flow sensor was replaced, and the unit was returned to service.

Event Description

The hospital reported the unit was delivering >20% less than what was requested in tidal volume.There was no report of patient involvement.

• Brand Name: AESPIRE 7100
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda drive; madison WI 53718
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 5996646
• MDR Text Key: 56374282
• Report Number: 2112667-2016-01940
• 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
• Report Date: 10/04/2016

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2016
• Initial Date FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2004
• 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