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

Device Problem Tidal Volume Fluctuations (1634)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information could not be obtained after multiple attempts.Attempts were made as follows: on (b)(6) 2016 (b)(6) - voicemail, (b)(6) 2016 - phone, (b)(6) 2016 - voicemail.A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The expiratory flow sensor was replaced, and the unit was returned to service.

Event Description

The hospital reported the unit over-delivered tidal volume during a case.The user altered the flow settings and the case was able to continue.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 drive; madison WI
• Manufacturer Contact: josewph seliga ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 6139177
• MDR Text Key: 61306443
• Report Number: 2112667-2016-02332
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050626
• 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: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2011
• 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