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

Model Number 712034

Device Problem Misassembled During Installation (4049)

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

Event Type  malfunction  

Event Description

During installation of the system, it was found that a couple of the rail connection blocks were mis-aligned in the ceiling unistrut.No injury reported.

Manufacturer Narrative

Ref.Id: 2367872 the investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.

• Brand Name: DIGITALDIAGNOST C90 HIGHPERFORMANCE
• 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: 16591770
• MDR Text Key: 311790058
• Report Number: 3003768251-2023-00011
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 00884838090699
• UDI-Public: 00884838090699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• 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: Other
• Device Model Number: 712034
• Device Catalogue Number: 712034
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 03/22/2023
• 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