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	09/23/2023
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 that tube descended when the user was manually adjusting the tube height for a wall stand scan.Our investigation concluded that the product problem would likely 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.
Event or Problem Description
This complaint has been evaluated based on the information provided; the issue reported was that tube descended when the user was manually adjusting the tube height for a wall stand scan.There was no injury/harm happened in this case.This malfunction was not likely to cause death or serious injury if it were to recur based on the risk evaluation result.Therefore, this issue has been determined not to be a reportable event.
Additional Manufacturer Narrative
Philips received a complaint on the digitaldiagnost c50 indicating that the tube descended approximately 30cm from a height of 150cm when the user was manually adjusting the tube height for a wall stand scan.There was no rescan performed and no allegation of death or serious injury.A philips authorized service provider engineer (aspe) inspected system and determined that the cs wire rope was broken.Customer contacted a third party to replace the cs wire rope and the device was operational after the repair was completed.According to the simulation test conducted by the system engineering team, if the steel rope was broken, there is only partial downward sliding of the cs telescopes motion when the power is off or the brakes are released, and the speed of descent is also low, which means that the risk of impact on the patient is limited.The risk of this issue remains in the accepted zone.Therefore, it is concluded that the reported malfunction was not likely to cause death or serious injury if it were to recur and 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: estelle hilas ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 17993494
• Report Number: 3009529630-2023-00016
• Device Sequence Number: 15134929
• Product Code: KPR
• UDI-Device Identifier: 00884838082366
• UDI-Public: 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup

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: 09/25/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2017
• 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
• Patient Race: Asian