MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7900; ANESTHESIA GAS MACHINE

Model Number 1006-9305-000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The flow sensor was replaced to resolve the reported issue.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.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 failure preventing mechanical ventilation.There was no report of patient injury.

• Brand Name: AESTIVA 7900
• 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: 9139007
• MDR Text Key: 201882084
• Report Number: 2112667-2019-00825
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K023366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1006-9305-000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2007
• 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