MalfunctionDSF
R50N RECORDER
Received Apr 11, 2012 · Event occurred Mar 16, 2012
Report 1220063-2012-00030 · MDR key 2539161
Device
Generic name
Bedside Recorder
Manufacturer
Draeger Medical Systems, Inc. (it/m)Model number
5740068Catalog number
5740068
Lot number
NA
Product problems
- False Device Output
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER COMPLAINED THAT AN R50N PRINTED 1/2 OF AN ECG STRIP WITH A PREVIOUS PT'S INFO THAT WAS ON THE M300 IN THE HEADER AND WAVEFORM. IT WAS FURTHER REPORTED THAT THE SECOND HALF OF THE STRIP DID CONTAIN THE CURRENT PT'S ECG. THERE WAS NO PT INJURY REPORTED. (B)(4).
Additional Manufacturer Narrative
DRAEGER IS STILL INVESTIGATING THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.