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	08/04/2023
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 completion of the investigation.Internal cross reference: complaint pr# (b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was ball tube dropped from telescopic to the lowest position and hit the examination table after an external power outage while device was sitting idle.This malfunction would likely to 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
Philips received a complaint on the digital diagnost c50 system indicating that the tube hit the examination table which occurred after scanning (normal shutdown).The device was in standby mode without patient involvement.There was no rescan performed and no allegation of death or serious injury.It was judged preliminarily over the phone that the cs suspension counterweight was unbalanced.Customer contacted a third party for repair and the device was operational after the repair was completed.No repair was performed by philips.Based on the information available, the cause of the reported problem was due to cs suspension counterweight being unbalanced.The device was operational after repairs were completed by a third party.The investigation concludes that no further action is required at this time.Internal cross reference: complaint #(b)(4).
Event or Problem Description
This complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was ball tube dropped from telescopic to the lowest position and hit the examination table after an external power outage while device was sitting idle.This malfunction would likely to 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
On 01-sep-2025 during a retrospective review of this report, it was identified that the udi information was inadvertently omitted.Additionally, the response to "labeled for single use? (rfb)" was incorrectly selected.This follow-up submission is being made to provide the complete and accurate udi data and to correct the erroneous selection.Following is the corrections made pertaining to emdr report number 3009529630-2023-00023 parent record ((b)(6)): product udi: changed from "blank" to "(b)(4), sn (b)(6)" response to "labeled for single use? (rfb)" was changed from "yes" to "no.".

• 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: 18070842
• Report Number: 3009529630-2023-00023
• Device Sequence Number: 7585421
• Product Code: KPR
• UDI-Device Identifier: 00884838082366
• UDI-Public: (01)00884838082366
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: 505
• Remedial Action: Repair,Inspection
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 10/23/2023; 10/23/2023
• Initial Report FDA Received Date: 11/05/2023
• Supplement Report FDA Received Date: 12/20/2023; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2018
• 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
• Patient Sex: Unknown