THD SLIDE OEN STERILE
Received Feb 5, 2015 · Event occurred Feb 18, 2013
Report 3006680097-2015-00004 · MDR key 4512140
Device
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THIS REPORT IS RELATED TO A POTENTIAL DOPPLER PROBE IMPROPER ACTIVATION ("ERROR #" CODE PROVIDED); NO INFO ABOUT PATIENT AND TREATMENT. HOWEVER, NO SERIOUS INJURY OR DEATH WERE REPORTED. THE DEVICE WAS NOT RECEIVED BACK FOR EVALUATION.
Additional Manufacturer Narrative
FOLLOWING A COMPLAINT RETROSPECTIVE REVIEW WE BECAME AWARE THAT IN THE ORIGINAL HANDLING OF THIS COMPLAINT NO MDR WAS SENT TO FDA. A COMPLAINT TREND ANALYSIS ON THE SAME THD SLIDE LOT CONCLUDED THAT NO OTHER SIMILAR COMPLAINTS WERE REPORTED ON THE SAME PRODUCTION LOT FOR ANY OF THE DEVICES INCLUDED IN THE KIT. MORE SPECIFICALLY, THE INVESTIGATION PERFORMED ON THE RETURNED DOPPLERS, INVOLVED IN SIMILAR EVENTS, GENERALLY SHOWS THAT IMPROPER ACTIVATION IS ASSOCIATED TO THE REPORTED 'ERROR #" CODE.