SENSICA SURESTEP TRAY
Received Apr 8, 2022 · Event occurred Mar 14, 2022
Report 1018233-2022-02149 · MDR key 14054247
Device
Generic name
Sensica Surestep tray
Manufacturer
C.r. Bard, Inc. (covington) -1018233Model number
SCCS1002Catalog number
A119108S
Lot number
NA
Product problems
- Nonstandard Device
- Device Sensing Problem
- Nonstandard Device
- Device Sensing Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN EVALUATION, THE SENSICA SYSTEM WITH A119108S WOULD NOT RECOGNIZE THE PRE-PRINTED TUBE BAND IN ORDER TO ADVANCE TO THE CALIBRATION SCREEN. MSS TRIED IT MULTIPLE DIFFERENT TIMES BUT COULD NOT GET IT TO WORK. WHEN THE MSS USED THE TUBE BAND THAT CAME WITH THE RING, THE SYSTEM RECOGNIZED IT RIGHT AWAY. THE DEVICE WAS NOT USED ON A PATIENT, BUT USED ONLY IN TRAINING.
Additional Manufacturer Narrative
PER INVESTIGATOR EVALUATION, BD HAS DETERMINED THAT THIS MDR EVENT IS NOT REPORTABLE. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN EVALUATION, THE SENSICA SYSTEM WITH A119108S WOULD NOT RECOGNIZE THE PRE-PRINTED TUBE BAND IN ORDER TO ADVANCE TO THE CALIBRATION SCREEN. MSS TRIED IT MULTIPLE DIFFERENT TIMES BUT COULD NOT GET IT TO WORK. WHEN THE MSS USED THE TUBE BAND THAT CAME WITH THE RING, THE SYSTEM RECOGNIZED IT RIGHT AWAY. THE DEVICE WAS NOT USED ON A PATIENT, BUT USED ONLY IN TRAINING.