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

Device Problem Defective Alarm (1014)

Patient Problem Cardiac Arrest (1762)

Event Date 07/05/2022

Event Type  Injury  

Manufacturer Narrative

Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.No patient information provided to date.Unique identifier: (b)(6).Legal manufacturer: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

The hospital reported a patient was connected to a carescape r860 when the unit did not alarm after a power disconnection.Reportedly, the patient desaturated and had a cardiac arrest.The patient was resuscitated and recovered.The hospital biomed tested the unit and determined it was working as intended and returned the unit to use.Ge healthcare will submit a follow-up report when the investigation has been completed.

Manufacturer Narrative

The hospital biomed tested the device following the reported issue and found no issues.Inspection by a ge field engineer found no source of malfunction or error and device log review identified no errors.The customer was not able to provide details explaining why they perceived the unit failed to alarm for a patient disconnected.The unit was placed back into clinical use by the hospital with no further issues reported.Based on the available information, there was no device malfunction and the device did not cause or contribute to an injury.

• Brand Name: CARESCAPE R860
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 15223850
• MDR Text Key: 297867410
• Report Number: 2112667-2022-02902
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K142679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/29/2022

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention