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

Model Number 1506-8600-000

Device Problem Defective Alarm (1014)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/12/2017

Event Type  malfunction  

Manufacturer Narrative

Replaced power management board to fix the reported issue.Patient information could not be obtained after multiple attempts.Attempts were made as follows: 8/7/2017 phone call, 8/8/2017 phone call, 8/9/2017 phone call.Unique device identifier: (b)(4).

Event Description

The hospital reported that, during patient use, the vent stopped and then restarted without alarming.There was no reported patient injury.

Manufacturer Narrative

According to gehc engineering review, the power management board failure impacted display only.Review of the logs revealed there was no loss of ventilation.Therefore, the initial mdr was not reportable.

• Brand Name: CARESCAPE R860
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI
• Manufacturer Contact: john szalinski ; 540 w. northwest highway; barrington, IL
• MDR Report Key: 6784055
• MDR Text Key: 82601386
• Report Number: 2112667-2017-01507
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-8600-000
• Other Device ID Number: SEE BLOCK H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2017
• 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