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

Device Problems Defective Alarm (1014); Unexpected Therapeutic Results (1631)

Patient Problem Hypoxia (1918)

Event Date 06/21/2018

Event Type  Injury  

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.Device evaluation anticipated, but not yet begun.

Event Description

"the hospital reported that the device changed ventilation-mode from bilevel to backup ventilation without any reason for changing and without alarming.The backup configuration didn`t fit the patient needs.The patient became hypoxic and had to be resusitated.".

Manufacturer Narrative

Incident date correction from (b)(6) 2018.Additional information: a ge healthcare service representative performed a checkout of the system.No errors or malfunctions were found.Ge healthcare engineering reviewed the service logs.The logs show that a system checkout was performed on the machine and all tests passed except the circuit check failed and the expiratory flow sensor check leak check failed.The user then bypassed system checkout prior to connecting the patient to the machine.The logs also showed that the machine continually alarmed with apnea and low minute volume alarms, causing the ventilator to continuously go into backup mode, which the user eventually turned off.This could not be duplicated and there is no indication of machine failure.The root cause in undetermined.Inappropriate ventilation settings by the user driven by an unidentified leak in the patient circuit can cause this condition.

• Brand Name: CARESCAPE R860
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: john szalinski ; 3000 n grandview blvd.; waukesha, WI
• MDR Report Key: 7746955
• MDR Text Key: 115923097
• Report Number: 2112667-2018-01537
• 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: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• 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: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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
• Patient Outcome(s): Other