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

Model Number	DIGITALDIAGNOST C50
Medical Device Problem Codes	Mechanical Jam (2983); Device Difficult to Maintain (3134)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.Upon completion, we will submit a follow-up report.Internal cross reference: complaint pr# (b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided.The reported issue is that the tube is too heavy to move with increased resistance.As a result, the user has reported experiencing pain in the arms, shoulders and neck.The user has been on acc nz leave for four days, receiving treatment from a physiotherapist and gp, and has been advised to consult a specialist following an mri scan.The full extent of the injury is currently under evaluation.Based on the available information, this issue has been determined to be a reportable event.
Additional Manufacturer Narrative
The customer reported that the system tube was too heavy to move with increased resistance following a potentiometer replacement.As a result, the user has been on leave with acc nz (accident compensation corporation) for four days, receiving treatment from a physiotherapist and gp, and has been advised to consult a specialist following an mri scan.The philips field service engineer (fse) visited the site to inspect the rails for obstructions; none were identified.Both lateral and longitudinal rails and castors were cleaned, and telescopic column tension was adjusted.Results were verified with the mrt and deemed satisfactory.The system was returned to full working condition.The complaint handling team, along with the system engineering team, analyzed the issue and determined that the root cause was spring degradation due to aging and prolonged use.As the spring force deteriorates, its capacity to counterbalance the suspended load is reduced.This requires greater manual effort to raise the tube, making the operation feel noticeably heavier and less ergonomic for the user.Under such circumstances, users should always contact philips service to perform spring balancer maintenance and restore proper balance.The system is currently fully operational without any issues.The investigation concludes that no further action is required at this time.

• Brand Name: DIGITALDIAGNOST C50
• Common Device Name: STATIONARY BASIC DIAGNOSTIC X-RAY SYSTEM, DIGITAL
• 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: 24290194
• Report Number: 3009529630-2026-100015
• Device Sequence Number: 9415152
• Product Code: KPR
• UDI-Device Identifier: 00884838082366
• UDI-Public: (01)00884838082366
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Inspection,Modification/Adjustment
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DIGITALDIAGNOST C50
• Device Catalogue Number: 712201
• 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: 01/30/2026
• Supplement Date Received by Manufacturer: 01/30/2026; 05/09/2026; 06/11/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/24/2026; 06/04/2026; 07/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown