MalfunctionMLD
CARDIOCAP 5
Received May 25, 2012 · Event occurred Apr 29, 2012
Report 9610105-2012-00023 · MDR key 2592048
Device
Generic name
Multi-parameter Patient Monitor
Manufacturer
Ge Healthcare Finland OyProduct problems
- No Audible Alarm
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THE BEEP TONES ASSOCIATED WITH A VITAL SIGNS PARAMETER WERE DISAPPEARING ON THE DEVICE. THOUGH THERE WAS NOT A MISSED ALARM ASSOCIATED WITH THIS ISSUE, ALL AUDIBLE SOUNDS DISAPPEARED FROM THE CARDIOCAP 5. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.