MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4.1 FLEX / VALUE; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number	DIGITALDIAGNOST 4.1 FLEX / VALUE
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).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 detector was dropped to the floor from a great height.The detector still works but they want to have it checked.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 is a direct digital radiography system with flat detector technology (fixed or mobile detectors) based on modular components to allow for customization for all radiographic applications and workload requirements.This radiography system is equipped with a motorized ceiling suspended column carrying the x-ray tube, collimator and control handle, a bucky table and a optional movable bucky wall stand for general x-ray examinations.As an option, a portable digital flat panel detector (model "skyplate") can be used for image capture.Philips field service engineer (fse) investigated on site.He checked the affected detector.No artefacts present.Detector is working as specified.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¿.The issue is further monitored and trended.

• Brand Name: DIGITALDIAGNOST 4.1 FLEX / VALUE
• Common Device Name: SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)
• 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: 16551241
• Report Number: 3003768251-2023-00006
• Device Sequence Number: 2906743
• Product Code: MQB
• UDI-Device Identifier: 00884838074514
• UDI-Public: 00884838074514
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141736
• 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: DIGITALDIAGNOST 4.1 FLEX / VALUE
• Device Catalogue Number: 712032
• 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: 02/17/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 09/13/2023
• 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