MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV/SEDECAL S.A. PHILIPS MOBILEDIAGNOST WDR 2.2; SYSTEM, X-RAY, MOBILE

Model Number WDR R2.2.X (712006)

Device Problems Product Quality Problem (1506); Problem with Software Installation (3013); Device Difficult to Maintain (3134)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/15/2023

Event Type  Injury  

Event Description

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: mw5117658, mw5117659, mw5117660, mw5117661, mw5117662, mw5117663, mw5117664, mw5117665, mw5117666, mw5117667, mw5117668.

• Brand Name: PHILIPS MOBILEDIAGNOST WDR 2.2
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV/SEDECAL S.A.
• MDR Report Key: 16960922
• MDR Text Key: 315682193
• Report Number: MW5117657
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WDR R2.2.X (712006)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening