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

Device Problem Increase in Pressure (1491)

Patient Problem Insufficient Information (4580)

Event Date 09/24/2022

Event Type  Injury  

Manufacturer Narrative

Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Customer declined to provide patient information.Legal manufacturer: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported inability to relieve airway pressure and loss of mechanical ventilation while using an aspire view.Reportedly, the patient was admitted to the pediatric icu as a consequence of the ventilation problem at the end of the intervention.쳌 the patient was reported in stable condition.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

A ge healthcare field engineer (fe) found no ventilation problems with the machine in terms of pressure or volume and the device passed all system checkout testing by the fe.The customer declined to provide pressure levels as well as confirmation that a preoperative checkout was performed prior to patient use.The root cause as to why the customer was unable to relieve the patients airway pressure is undetermined.

• Brand Name: AESPIRE VIEW
• Type of Device: ANESTHESIA GAS MACHINE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 15679004
• MDR Text Key: 302468874
• Report Number: 2112667-2022-04405
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K172045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1