MAUDE Adverse Event Report: DATEX-OHMEDA, INC. CARESCAPE R860; VENTILATOR, CONTINUOUS, FACILITY USE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Cardiac Arrest (1762)

Event Date 01/31/2021

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.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.Unique identifier: (b)(4).

Event Description

The hospital reported that the ventilator alarm sounded.In less than 30 seconds, it was observed that the ge ventilator screen was black with a message: ⫠ventilator failure - prepare to disconnect the patient from the ventilator and manually ventilate the patient.- contact a qualified technician.» the patient was disconnected from the ventilator and ventilation was resumed manually.Resuscitation maneuvers were performed without success.The patient died.

Manufacturer Narrative

A ge healthcare service representative retrieved the device logs but did not perform any tests per customer request.Ge healthcare product engineering performed an investigation of this event.The ventilator logs show that the ventilator display lost power, then regained power while the ventilator continued to ventilate the patient.When the ventilator display regained power, all the subsystems were already running, so the ventilator display could not complete the bootup sequence and communicate with the subsystems.This caused the ventilator to display the ventilator failure쳌 message.Per the ventilator user manual, when this internal error occurs, it states, the ventilator will continue to ventilate the patient with the current settings and show this [ventilator failure] message on the display".However, it may be difficult to visually see if the patient is still being ventilated from chest movement or by listening to sounds from the heart, lungs, or other organs.Therefore, the ventilator user manual also states that, access to an appropriate alternative means of ventilation at all times is required to prevent patient injury or death in the event of ventilator failure.쳌 since the ventilator display is unavailable to make changes to ventilation, it is up to the clinician to decide if the patient should be manually ventilated while attempting to reboot the ventilator, manually ventilate while securing alternate ventilation, or to transfer the patient to an alternate source of ventilation.In this case, the patient was removed from the ventilator and manually ventilated, and suffered a cardiac arrest due to the patient âs critical condition.

• Brand Name: CARESCAPE R860
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• MDR Report Key: 11397926
• MDR Text Key: 234206826
• Report Number: 2112667-2021-00554
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K142679
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• 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: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death