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

Model Number 712031

Device Problems Poor Quality Image (1408); Device Handling Problem (3265); Device Fell (4014)

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

Event Type  malfunction  

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 Description

The customer has dropped the skyplate detector and now has a line in the image.A dropped detector can lead in worst case to a fracture in the foot.No injury reported.

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.The local field service engineer (fse) was asked to replace the skyplate.After further investigation it was revealed that the affected detector was dropped.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).A new detector was ordered and installed.Finally, the system meets the specification for the performed service and is returned to use.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 HIGH PERFORMANCE
• 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: 17508925
• MDR Text Key: 320895974
• Report Number: 3003768251-2023-00046
• Device Sequence Number: 1
• Product Code: MQB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K141736
• 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,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
• Device Operator: Health Professional
• Device Model Number: 712031
• Device Catalogue Number: 712031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 02/06/2024
• 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