Description of Event or Problem · 0
ON (B)(6) 2023, ALL PHILIPS DIGITAL DIAGNOST PORTABLE X-RAYS ACROSS THE COUNTRY CEASED FUNCTIONING WITHOUT WARNING. ACROSS THE MCLAREN SYSTEM, 12 UNITS AT SIX DIFFERENT HOSPITALS WERE AFFECTED. THE LARGEST IMPACT WAS AT (B)(6) WHERE ALL UNITS FAILED AND PATIENT CARE WAS SIGNIFICANTLY AFFECTED AS NO PORTABLE X-RAYS WERE ABLE TO BE CONDUCTED FOR 2 DAYS. ON (B)(6) PHILIPS INDICATED THE CAUSE OF THE ISSUES WAS IDENTIFIED AS A CERTIFICATE PROTECTING THE ELEVA USER LOGIN WHICH EXPIRED. THE PROPOSED SOLUTION IS TO UPGRADE TO SOFTWARE 2.2.4, BUT NO SCHEDULE HAS BEEN PROVIDED TO REMEDIATE OUR SYSTEMS. (B)(6) REQUESTED THE CAPA INFORMATION ON THIS ISSUE, AND THE CORRECTIVE ACTION WAS CLEAR, HOWEVER (B)(6) WAS UNABLE TO GET A PREVENTIVE ACTION PLAN TO ENSURE THIS EVENT DOESN'T OCCUR AGAIN. (B)(6) IS REQUESTING FDA OPEN AN INVESTIGATION INTO THIS NATIONAL ISSUE AND ENSURE PHILIPS HAS THE QUALITY MANAGEMENT SYSTEM AND APPROPRIATE CUSTOMER COMMUNICATIONS IN PLACE TO AVOID THIS TYPE OF ISSUE IN THE FUTURE. PLANS SHOULD ENSURE IMPLEMENTATION OF SAFEGUARDS SO THAT ENTIRE PRODUCT LINES ACROSS THE COUNTRY AREN'T RENDERED USELESS AT ANY TIME WITHOUT WARNING. THE PATIENT IMPACT OF THIS OUTAGE WILL CONTINUE UNTIL THE SOFTWARE UPDATE IS COMPLETE. REFERENCE REPORTS: MW5117657, MW5117658, MW5117659, MW5117660, MW5117661, MW5117662, MW5117664, MW5117665, MW5117666, MW5117667, MW5117668.