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

Device Problem Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.It was noted the inspiratory flow sensor flapper was stuck to the top of the housing.The flow sensor was replaced, and the unit was returned to service.The customer contact informed ge healthcare that the patient information is not available for the reported event.(b)(6).

Event Description

The hospital reported the tidal volume set and the tidal volume delivered did not match.There was no report of patient injury.

• Brand Name: AESPIRE VIEW
• 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: brad wheeler ; 3000 n. grandview blvd., w450; waukesha, WI 53188
• MDR Report Key: 5496034
• MDR Text Key: 40202725
• Report Number: 2112667-2016-00468
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092864
• 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: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• 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: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2014
• 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