MOBILEDIAGNOST WDR 2.2

Description of Event or Problem

A CUSTOMER IN THE US REPORTED THAT THEIR MOBILEDIAGNOST WDR 2.2 SYSTEM WAS NON-OPERATIONAL AS THE USER COULD NOT LOG IN. THE CUSTOMER HAD MULTIPLE UNITS AT SIX DIFFERENT SITES THAT WERE AFFECTED. THE CUSTOMER FURTHER STATED THAT "PATIENT CARE WAS SIGNIFICANTLY AFFECTED AS NO PORTABLE X-RAYS WERE ABLE TO BE CONDUCTED FOR TWO DAYS". PHILIPS HAS RECEIVED MULTIPLE MEDWATCH REPORTS FOR THE REPORTED EVENTS FROM THIS HEALTHCARE FACILITY. FOR THE REPORTED EVENT THAT IS IN THE SCOPE OF THIS REPORT (MEDWATCH REPORT MW 5117657), THE COMPLAINANT COMPLETED SECTION "ADVERSE EVENT OR PRODUCT PROBLEM" OF THE MEDWATCH FORM WITH THE FIELD "OUTCOMES ATTRIBUTED TO ADVERSE EVENT" LISTED AS "LIFE THREATENING". IN ADDITION, THE COMPLAINANT COMPLETED THE MEDWATCH REPORT FORM SECTION "DEVICE MANUFACTURERS ONLY" WITH THE FIELD "TYPE OF EVENT LISTED AS "SERIOUS INJURY". PHILIPS HAS MADE MULTIPLE ATTEMPTS TO GET FURTHER INFORMATION REGARDING THE ALLEGED "PATIENT INJURIES", AND THE ALLEGED "LIFE THREATENING EVENT". SO FAR, PHILIPS HAS NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THESE EVENTS FROM THE COMPLAINANT. WE ARE REPORTING THIS EVENT OUT OF ABUNDANCE OF CAUTION. OUR INVESTIGATION OF THIS EVENT IS ON-GOING. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION.