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

Model Number 1009-9212-000

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The ez change assembly, check valve and orings were replaced to resolve the issue.No patient information available.

Event Description

The hospital reported an error that results in high co2 delivery.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 dr,; madison, WI 53718
• Manufacturer Contact: john szalinski
• MDR Report Key: 11100479
• MDR Text Key: 224535342
• Report Number: 2112667-2020-03669
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172045
• 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: 12/31/2020

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
• Device Model Number: 1009-9212-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/31/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2011
• 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