MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4.1 CHEST / EMERGENCY; SYSTEM, X-RAY, STATIONARY

Model Number	712033
Medical Device Problem Codes	Device Handling Problem (3265); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref.Id: (b)(4).Philips field service engineer investigated on site.The affected detector fell and gave stripes artefacts.After calibration the lines were gone but after a few days they appeared again.Detector needs to be replaced.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 the portable detector fell.A dropped detector can lead in worst case to a fracture in the foot.No injury reported.
Additional Manufacturer Narrative
Ref.Id: (b)(4).The digitaldiagnost r4.X is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector (model "skyplate") can be used for image capture.Philips field service engineer investigated on site.The affected detector fell and gave stripes artefacts.After calibration the lines were gone but after a few days they appeared again.Detector needs to be replaced.The detector was replaced by the customer.No details were provided about the circumstances when the detector fell down.As the customer did not make other claims, it is concluded that the detector was dropped by accident (use error).Risk estimation revealed acceptable risk per risk benefit analysis, because actually, there is no feasible technical solution for this kind of ¿use error¿.This issue is further monitored and trended.

• Brand Name: DIGITALDIAGNOST 4.1 CHEST / EMERGENCY
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS DMC GMBH; roentgenstrasse 24; hamburg 22335 ; GM 22335
• Manufacturer Contact: dusty leppert ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 19213370
• Report Number: 3003768251-2024-00025
• Device Sequence Number: 8105784
• Product Code: KPR
• UDI-Device Identifier: 00884838074521
• UDI-Public: 00884838074521
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K210692
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 712033
• Device Catalogue Number: 712033
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown