OFFICEPACS POWER CLIENT SOFTWARE
Received Sep 4, 2009 · Event occurred Aug 5, 2009
Report 1064427-2009-00003 · MDR key 1492617
Device
Product problems
- Computer Software Problem
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PER THE INITIAL REPORTER, IT WAS ALLEGED THAT PATIENT DATA INCORRECTLY MERGED WITH ANOTHER PATIENT'S DATA. UPON FURTHER INVESTIGATION AND SERVICE, STRYKER SPLIT OUT THE AFFECTED STUDIES BY GOING INTO THE SQL DATABASE FOR OFFICEPACS. THE PATIENT DATA WAS NOT LOST AND NO ADDITIONAL RE-IMAGING WAS REQUIRED. NO ADVERSE CONSEQUENCES OCCURRED.
Additional Manufacturer Narrative
NO PATIENT INVOLVED. THERE IS NO ESTABLISHED EXPIRATION DATE FOR THIS DEVICE. DEVICE MANUFACTURED DATE IS UNKNOWN AT THIS POINT. DEVICE EVALUATION ANTICIPATED. SUPPLEMENTAL WILL BE SUBMITTED WITH ADDITIONAL DETAILS. NO PATIENTS WERE INVOLVED AND NO ADVERSE CONSEQUENCES OCCURRED. THIS IS NOT A SINGLE-USE DEVICE.
Remedial action
- Other