MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST C90 FLEX/VALUE/CHEST/EMERGENCY ROOM; SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)

Model Number 712035

Device Problems 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 local field service engineer (fse) went on site and confirmed the reported problem: the portable detector model skyplate had fallen out of hand during positioning and the detector shows no more images after the drop.The affected 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 Description

The customer reported that the portable detector fell down during positioning under a patient.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 c90 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) went on site and confirmed the reported problem.The portable detector model skyplate had fallen out of hand during positioning (use error) and the detector shows no more images after the drop.The affected detector needs to be replaced.Fse started the replacement process for the defect detector.The customer decided not to order a new detector until the corresponding quote expired.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 C90 FLEX/VALUE/CHEST/EMERGENCY ROOM
• 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: 18939354
• MDR Text Key: 338086656
• Report Number: 3003768251-2024-00009
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 00884838090705
• UDI-Public: 00884838090705
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K182973
• 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: 712035
• Device Catalogue Number: 712035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2020
• 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