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

Model Number	REQUIRED
Medical Device Problem Codes	Device Handling Problem (3265); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref.Id: (b)(4).Philips field service engineer investigated on site.He checked detector for damages, checked function, retrieved shock logs.The system is functioning correctly.The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.
Event or Problem Description
The customer reported that a patient threw the detector and they want to find out if there is anything wrong with it.No patient or user harmed.
Additional Manufacturer Narrative
Ref.Id: (b)(4).The issue reported was that the patient threw the detector and customer would like to find out if there's anything wrong with it.There's no allegation of patient/user/by stander harm in this record.Philips field service engineer went to site, inspected system and confirmed that system's working as specified without malfunction.Fse also retrieved both shock logs and system logs for the national support specialist(nss) for analysis whom confirmed that system is working as specified.Based on above assessment, this issue has been determined not to be a reportable event.
Event or Problem Description
The customer reported that a patient threw the detector and they want to find out if there is anything wrong with it.No patient or user harmed.

• Brand Name: DURADIAGNOST
• 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: li xin ; no. 258, zhongyaun road; suzhou industrial park; suzhou jiangsu 21502-4 ; CH 215024
• MDR Report Key: 16406474
• Report Number: 3009529630-2023-00001
• Device Sequence Number: 6279308
• Product Code: KPR
• UDI-Device Identifier: 00884838064751
• UDI-Public: 00884838064751
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K141381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• 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: REQUIRED
• Device Catalogue Number: 712214
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2019
• 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