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

Model Number	DIGITALDIAGNOST C50 WIN10
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: the investigation of this event is still ongoing.A follow-up emdr report will be submitted upon completion of the investigation.Internal cross reference: complaint (b)(4).
Event or Problem Description
It was reported that the overhead tube fell down due to defective cable corrugate support.There is no allegation of death or serious injury.However, it is uncertain whether this event is likely to recur and potentially cause serious injury.Based on the available information, this issue has been determined to be a reportable event.Philips has initiated an investigation into this complaint.
Additional Manufacturer Narrative
16-jun-2025.Issue description: philips received a complaint regarding the digitaldiagnost c50 system, stating that the corrugated hose became detached during clinical use.No allegations of death or serious injury were reported.Investigation findings: the field service engineer (fse) conducted an onsite analysis and confirmed the reported issue: the corrugated hose support had detached.Fse replaced the defective cable corrugated support and returned the part for further analysis.The philips r&d team performed a root cause analysis and identified the following: -the holder¿s nut and screw are intentionally designed without a locking mechanism, permitting free rotation during cs movement.Over time, repeated motion causes thread wear, loosening the screw-nut connection and eventually leading to detachment of the connection rod.However, the cable hose remains securely suspended due to its natural elasticity, stiffness, and three-point fixation.The detached component poses no risk of personnel contact or wire exposure.Design evaluation: material selection: the screw (low-carbon steel) and nut (stainless steel) are known for their high hardness, rigidity, and wear resistance, which benefits in minimizing the probability of threads wore.Additionally, these materials are commonly used for screw and nut.Reliability testing: the cable hose holders are secured to the auxiliary rails of both longitudinal and lateral rail systems.Reliability testing for longitudinal and lateral movements has been successfully completed, with all results meeting specifications.The design fulfills the durability requirement for 10 years of operation.Root cause analysis: based on the information available and the testing conducted, the cause of the reported problem was wear and tear.Preventive actions: the following preventive actions should be implemented to avoid recurrence of this issue.-according to pm (preventive maintenance) manual, during pm activities, cables and the corrugated hoses checking are required to be performed annually, which can reduce the potential issues that may cause hose holder fall.-in the instruction for use (ifu) it was clearly defined that this product requires proper operation, planned maintenance, and checks the user must perform routinely, which are essential to keep the product operating safely, effectively and reliably.Resolution: -the fse replaced the cable corrugated support and confirmed that the system was working fine.System returned to clinical use with full functionality.Final reportability assessment: -the reporting decision was re-evaluated based on the updated risk assessment.The system did not cause or contribute to a death or serious injury.The reported issue does not affect system functionality but presents a negligible risk due to the potential detachment of the hose holder, it would not be likely to cause or contribute to a death or serious injury if this were to recur.Therefore, this issue has been determined not to be a reportable event.

• 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: 21915810
• Report Number: 3009529630-2025-000009
• Device Sequence Number: 4210378
• Product Code: KPR
• UDI-Device Identifier: 00884838095199
• UDI-Public: (01)00884838095199
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 04/15/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/27/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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