MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH PROGRADE R1; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number	PROGRADE R1
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	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: (b)(4).The field service engineer (fse) performed analysis and concluded that detector was dropped.After inspection, the detector passed both the interface and self-tests.Gain and pixel calibrations were performed, and no artifacts were found.Based on the information available and the testing conducted, the cause of the reported problem was detector drop.The reported problem was confirmed by the customer.Thus, it is concluded that the detector was dropped by accident (use error).The device was calibrated & returned to clinical use.
Event or Problem Description
The customer reported that the detector kept randomly turning off and that the portable detector was dropped.The device was not in clinical use and there was no patient or user impact.

• Brand Name: PROGRADE R1
• 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: 20758800
• Report Number: 3003768251-2024-000090
• Device Sequence Number: 15621059
• Product Code: MQB
• UDI-Device Identifier: 00884838074538
• UDI-Public: (01)00884838074538
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: PROGRADE R1
• Device Catalogue Number: 712090
• 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: 10/25/2024
• Initial Report FDA Received Date: 11/22/2024
• 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): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown