MAUDE Adverse Event Report: DATEX-OHMEDA, INC. ENGSTROM; CRITICAL CARE VENTILATER

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Death (1802)

Event Date 02/09/2020

Event Type  Death  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information available at time of filing.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that while in use on a patient, the system alarmed and subsequently shut down resulting in a loss of mechanical ventilation.The hospital also reported that after this event, the patient died from causes not related to the ge healthcare ventilator.

Manufacturer Narrative

After the event, a ge healthcare field engineer evaluated the system and system logs.A system checkout was performed.The circuit leak test failed.The exhalation housing was leaking.The exhalation housing was replaced.The checkout was performed again and passed.Per engineering recommendation, the ventilator control board (vcb) was replaced.The original vcb was returned to ge healthcare product engineering for evaluation.Ge healthcare product engineering performed an investigation of this event.The returned vcb was installed into another unit for testing.The ventilator ran for a week and the reported shutdown could not be duplicated.The system logs were also reviewed, and it was concluded that the device did not malfunction while the patient was on the ventilator, but did shut down after the patient was removed from the ventilator.The root cause of the reported issue is undetermined because the issue could not be duplicated.The customer respiratory therapy manager stated that the patient died a day or two later but not due to the ventilator issue.Therefore, the ventilator did not cause harm to the patient or contribute in the patient's death in the days following the incident.

• Brand Name: ENGSTROM
• Type of Device: CRITICAL CARE VENTILATER
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 9819557
• MDR Text Key: 182981581
• Report Number: 2112667-2020-00694
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K041775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death