MalfunctionCBL
CARESCAPE R860
Received Dec 26, 2018 · Event occurred Nov 27, 2018
Report 2112667-2018-02552 · MDR key 8197045
Device
Generic name
Ventilator, Continuous, Facility Use
Manufacturer
Datex-ohmeda, Inc.Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
A GE HEALTHCARE SERVICE REPRESENTATIVE REPLACED THE MAIN VENTILATOR HOUSING TO RESOLVE THE REPORTED ISSUE. NO REPORT OF PATIENT INVOLVEMENT. (B)(4). THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.
Description of Event or Problem
A GE HEALTHCARE SERVICE REPRESENTATIVE REPORTED THAT THE TROLLEY LOCKING PART IN THE HOUSING SECTION WAS BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.