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

Model Number 1011-9000-000

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 06/03/2019

Event Type  malfunction  

Manufacturer Narrative

The customer biomedical engineer troubleshot the issue with ge healthcare technical support.The customer replaced the advanced breathing system which resolved the issue.No patient information available after three attempts.Date received by manufacturer: this mdr malfunction event was previously eligible for the voluntary malfunction summary reporting (vmsr) program.As of 9/16/2019 notification from fda, this product code is no longer eligible for vmsr.According to the notification, ge healthcare must submit individual reports within 30 calendar days of receiving the notification.Therefore, this event is being reported as an individual mdr report due 10/16/2019.

Event Description

The hospital reported a flow sensor error preventing manual ventilation.There was no report of patient injury.

• Brand Name: AISYS
• 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: 9115491
• MDR Text Key: 199889848
• Report Number: 2112667-2019-00510
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042154
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1011-9000-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2011
• 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