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

Device Problem Moisture Damage (1405)

Patient Problem Death (1802)

Event Date 05/06/2020

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 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 a patient diagnosed with covid-19 had been ventilated for over two weeks on this device when the unit alarmed.The device was checked and found to contain water in the expiratory valve water trap.The patient was moved to a different ventilator and passed away sometime later.

Manufacturer Narrative

A ge healthcare service representative performed a checkout of the system but found the unit operating as expected with no issues.The system logs were reviewed.An oxygen sensor error message was noted so the oxygen sensor calibration was performed which resolved the reported issue.The last system verification performed by a ge healthcare service representative was completed on 21-mar-2019.Ge healthcare product engineering investigated this event.The customer was utilizing active humidification for this patient.The user reference manual (urm) states that the water trap should be emptied "as necessary" which can be done while in use.The water trap is clear and located on the front of the device for easy monitoring.The system logs indicate multiple days of persistent machine alarming while the device continued to ventilate.Between (b)(6) 2020 at 10:40am until (b)(6) 2020 at 8:00am there were alarms for high paw쳌 (high patient airway pressure) and vt expir low쳌 (low expiratory tidal volume) totaling 2,736 alarms over four days before the patient was transferred from the system.Alarms were silenced 15 times in this timeframe.

• 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: 10105281
• MDR Text Key: 193051832
• Report Number: 2112667-2020-01593
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death