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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 11/13/2019

Event Type  Death  

Manufacturer Narrative

Ge healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported that in the early morning of (b)(6) 2019, a patient died while receiving mechanical ventilation in the intensive care unit after a surgical procedure.

Manufacturer Narrative

The customer opened a service case requesting a technical inspection and report of the system's status in order to ensure that the ventilator was working properly.A ge healthcare service representative performed a checkout of the system and a review of the logs.The checkout results, functional tests, error, event, and alarm logs were reviewed.No errors were found.The system was found 100% functional and working properly.Ge healthcare product engineering performed an investigation of this event.The customer did not allege that the machine failed.Engineering review of the logs indicates there was no malfunction of the device, it performed as intended, and there was no evidence of user error.Because there was no allegation of failure and no functional fault found, this event was not reportable.

• Brand Name: ENGSTROM CARESTATION
• Type of Device: CRITICAL CARE VENTILATER
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 9449848
• MDR Text Key: 170218972
• Report Number: 2112667-2019-02543
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death