MAUDE Adverse Event Report: PHILIPS HEALTHCARE (SUZHOU) CO., LTD. DIGITALDIAGNOST C50; SYSTEM, X-RAY, STATIONARY

Model Number	DIGITALDIAGNOST C50 WIN10
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.We will file a follow-up emdr at the complete of the investigation.Internal cross reference: complaint (b)(4).
Event or Problem Description
This complaint was reviewed.The customer reported observing shavings descending from the rails.There's no allegation of death or serious injury.However, considering that a similar incident has previously occurred on the same device lead to an eye injury, this event has been determined to be a reportable one.Philips has started the investigation of this event.
Additional Manufacturer Narrative
On 28-aug-2025: during a retrospective review of this report, it was identified that the udi information was inadvertently omitted.This follow-up submission is being made to provide the complete and correct udi data.
Additional Manufacturer Narrative
Philips received a complaint regarding the digitaldiagnost c90 system, concerning metal shavings falling from the rails.The device was in clinical use and there was no patient or user harm.The field service engineer (fse) conducted an inspection and discovered that the small metal pieces originated from the brake pads of the system.The fse then cleaned the longitudinal and lateral ceiling rails and tested the system's geometry functions, which all passed.The philips complaint handling team, along with the system engineering team, analyzed the issue and concluded that there was no design defect of the system.The observed problem was due to gradual mechanical wear, which is a natural occurrence in systems with multi-directional movement.The design already includes several preventive measures, such as wear-resistant components and particle collection systems.With the corrective actions taken, including updates to maintenance documentation and the introduction of enhanced components, the risk of recurrence can be significantly reduced through regular system maintenance as specified in the instructions for use and updated planned maintenance procedures.The system is currently in full operation status without any issues.

• Brand Name: DIGITALDIAGNOST C50
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS HEALTHCARE (SUZHOU) CO., LTD.; no. 258, zhongyaun road; suzhou industrial park; suzhou jiangsu 21502 4; CH 215024
• Manufacturer (Section G): PHILIPS HEALTHCARE (SUZHOU) CO., LTD.; no. 258, zhongyaun road; suzhou industrial park; suzhou jiangsu 21502 4; CH 215024
• Manufacturer Contact: miley xu ; no. 258, zhongyaun road; suzhou industrial park; suzhou jiangsu 21502-4 ; CH 215024
• MDR Report Key: 22392517
• Report Number: 3009529630-2025-000011
• Device Sequence Number: 9126914
• Product Code: KPR
• UDI-Device Identifier: 00884838095199
• UDI-Public: (01)00884838095199
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K163410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIGITALDIAGNOST C50 WIN10
• Device Catalogue Number: 712204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 06/26/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/06/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown