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 it was not correctly attached to the ceiling unistrut.Some of the fixing blocks are not properly seated in the unistrut, no injury reported.

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.

Manufacturer Narrative

Ref.Id: (b)(4).The digitaldiagnost c90 is intended to acquire, process, store, display and export digital radiographic images.The systems consists of several components that can be combined in various configurations to form x-ray systems.One component is the celling suspension to which the x-ray tube with the collimator is attached.To get the ceiling suspension connected to the ceiling, anchor rails must be mounted into the ceiling, these anchor rails can be of different types e.G.¿unistrut¿.During completion of installation it was discovered a misalignment of fixing blocks and unistrut anchor rails.Some of the fixing blocks are not properly seated in the ¿unistrut¿ anchor rails by a 3rd party.A capa investigation revealed that more than this system were affected.The problem on the affected systems was resolved by an field corrective action (fco71200234).As a preventive action the installation documention was improved.A finite element analysis (fea) carried out simulating wrong installation of unistrut & its fixation parts to evaluate the impact on system performance with the result that none of the fixing parts will fall down, the system will work as intended, no obstruction during intended use.No potential safety and/or performance issue will occur due to this issue.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.Additional: z-0276-2024, z-0277-2024, z-0278-2024.The event was originally reported to the authorities as not enough information was available to make a definite reportability decision.Since that time, additional information was received which revealed that the event does not meet the criteria for reporting.

• 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: 15917110
• MDR Text Key: 308001577
• Report Number: 3003768251-2022-00010
• 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: 06/13/2022
• Initial Date FDA Received: 12/05/2022
• 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