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

Model Number	DIGITALDIAGNOST C50
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.Customer reported that after the shutting the system down, tube head automatically fell down.This event was identified outside of clinical use, during regular shut down of the system.However, this malfunction would potentially cause or contribute to a serious injury if this were to recur.Based on the available information, this issue has been determined to be a reportable event.Philips has started the investigation of this event.
Additional Manufacturer Narrative
Note: we have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr# (b)(4).
Additional Manufacturer Narrative
This report is based on information provided by a philips authorized service provider engineer (aspe) and has been investigated by the philips complaint handling team.The issue reported was that the machine head automatically fell down on the digitaldiagnost c50 device.The device was in standby mode without patient involvement.Based on the information available, the cause of the reported problem was due to cs suspension counterweight being unbalanced.Customer contacted a third party for repair and the device was operational after the repair was completed.No repair was performed by philips.System was returned to the customer in good working order after the repair.No further action is necessary at this time.
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.Customer reported that after the shutting the system down, tube head automatically fell down.This event was identified outside of clinical use, during regular shut down of the system.However, this malfunction would potentially cause or contribute to a serious injury if this were to recur.Based on the available information, this issue has been determined to be a reportable event.Philips has completed the investigation of this event.
Additional Manufacturer Narrative
(b)(6) 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.Following is the corrections made pertaining to emdr report number 3009529630-2024-00003(parent (b)(6)): product udi: changed from "blank" to (b)(4).

• 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: estelle hilas ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 18891775
• Report Number: 3009529630-2024-00003
• Device Sequence Number: 20732477
• Product Code: KPR
• UDI-Device Identifier: 00884838082366
• UDI-Public: (01)00884838082366(21)SN180052
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2025

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
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; 03/06/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 04/02/2024; 09/02/2025
• 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