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

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2018

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the equipment and was not able to confirm the reported complaint.The co2 canister was replaced by the biomedical engineer, and the unit was returned to service.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.

Event Description

The hospital reported the unit was delivering high c02.There was no report of patient involvement.

Manufacturer Narrative

Additional information was received that high co2 delivery was not duplicated by the ge service representative.The unit continues to ventilate and alarms remain functional.Co2 monitoring is part of standards for monitoring.The equipment was checked and found to function within manufacturing specifications.The reported complaint could not be duplicated.

• Brand Name: AESPIRE VIEW
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7964822
• MDR Text Key: 123684228
• Report Number: 2112667-2018-02035
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K092864
• 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: 01/09/2019

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: 09/15/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/09/2019
• 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