| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | POWERORDERS - NOT A MEDICAL DEVICE | SOFTWARE | CERNER CORPORATION | LNX | 2012.01 - 2015.01 | N/A | N/A | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-12-12 | 0 |
Patient 1
CERNER DISTRIBUTED A PRIORITY REVIEW FLASH NOTIFICATION (FLASH16-0659-0) ON DECEMBER 5, 2016 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, AN ALTERNATIVE WORKFLOW AND NOTIFICATION THAT A SOFTWARE MODIFICATION IS BEING DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION WILL PROVIDE A FOLLOW-UP REPORT WHEN THE SOFTWARE MODIFICATION IS AVAILABLE.
Patient 1
THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S MILLENNIUM POWERORDERS. THE ISSUE OCCURS IN POWERORDERS WHEN THE USER ADDS AND SIGNS MORE THAN ONE ELECTRONIC PRESCRIPTION ORDERABLE ITEM AND ONE OF THE ORDERABLE ITEMS CONTAINS AN INVALID CHARACTER OUTSIDE OF THE ASCII 32-126 CHARACTERS IN THE SPECIAL INSTRUCTIONS. THIS WILL RESULT IN THOSE SPECIAL INSTRUCTIONS TO BE APPLIED TO ALL ORDERABLE ITEMS.?THIS ISSUE COULD RESULT IN A PATIENT TAKING PRESCRIBED MEDICATIONS IN A MANNER OTHER THAN WHAT THE PRESCRIBER INTENDED AND COULD LEAD TO NEGATIVE PATIENT REACTIONS. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT OF THIS ISSUE.
Patient 1
CERNER DISTRIBUTED A PRIORITY REVIEW FLASH NOTIFICATION (FLASH16-0659-0) ON DECEMBER 6, 2016 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDED A DESCRIPTION OF THE ISSUE, AN ALTERNATIVE WORKFLOW AND NOTIFICATION THAT A SOFTWARE MODIFICATION WAS DEVELOPED TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER DISTRIBUTED AN UPDATED PRIORITY REVIEW FLASH NOTIFICATION (FLASH16-0659-0) ON APRIL 19, 2017 TO ALL POTENTIALLY IMPACTED CLIENT SITES. THE SOFTWARE NOTIFICATION INCLUDES A DESCRIPTION OF THE ISSUE, AN ALTERNATIVE TO PREVENT THE ISSUE FROM OCCURRING, AND NOTIFICATION THAT A SOFTWARE MODIFICATION HAS BEEN DEVELOPED AND IS AVAILABLE TO ADDRESS THE ISSUE FOR ALL SITES THAT COULD BE POTENTIALLY IMPACTED. CERNER CORPORATION CONSIDERS THE ISSUE RESOLVED AND NO FURTHER NARRATIVE IS REQUIRED FOR FOLLOW-UP.
Patient 1
THE SOFTWARE PRODUCT MENTIONED IN THIS MEDWATCH REPORT MAY NOT BE, BY DEFINITION, A MEDICAL DEVICE; HOWEVER, CERNER HAS CHOSEN TO FILE THIS MEDWATCH REPORT IN ORDER TO VOLUNTARILY NOTIFY THE FDA OF A MALFUNCTION ASSOCIATED WITH THIS SOFTWARE PRODUCT. THIS REPORT DOCUMENTS INFORMATION RELATED TO AN ISSUE IDENTIFIED WITH FUNCTIONALITY INCLUDED IN CERNER'S MILLENNIUM POWERORDERS. THE ISSUE OCCURS IN POWERORDERS WHEN THE USER ADDS AND SIGNS MORE THAN ONE ELECTRONIC PRESCRIPTION ORDERABLE ITEM AND ONE OF THE ORDERABLE ITEMS CONTAINS AN INVALID CHARACTER OUTSIDE OF THE ASCII 32-126 CHARACTERS IN THE SPECIAL INSTRUCTIONS. THIS WILL RESULT IN THOSE SPECIAL INSTRUCTIONS TO BE APPLIED TO ALL ORDERABLE ITEMS. THIS ISSUE COULD RESULT IN A PATIENT TAKING PRESCRIBED MEDICATIONS IN A MANNER OTHER THAN WHAT THE PRESCRIBER INTENDED AND COULD LEAD TO NEGATIVE PATIENT REACTIONS. CERNER HAS NOT RECEIVED COMMUNICATION ON ANY ADVERSE PATIENT EVENTS AS A RESULT OF THIS ISSUE.