MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 3.1.X; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712026

Device Problems Device Handling Problem (3265); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported that the portable detector is damaged after it was hit.No injury reported.

Manufacturer Narrative

Ref.Id: (b)(4).The digitaldiagnost 3.X is a stationary x-ray system for general radiographic purposes.As an option, a portable digital flat panel detector can be used for image capture.The philips service engineer instructed the customer remotely to do a calibration but the calibration was not successful so a replacement of the detector was proposed.A quote for a refurbished detector was sent to the customer but they did not order until it expired.Later, upon request, the customer confirmed that the portable detector was dropped from the user hands when swapping from the table to the wall bucky (use error).A dropped detector can lead in worst case to a fracture in the foot.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 3.1.X
• Type of Device: 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: 18092519
• MDR Text Key: 328601335
• Report Number: 3003768251-2023-00058
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

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
• Device Operator: Health Professional
• Device Model Number: 712026
• Device Catalogue Number: 712026
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1