MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS DMC GMBH DIGITALDIAGNOST 4.1 CHEST / EMERGENCY; SYSTEM, X-RAY, STATIONARY

Model Number	712033
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tube is nearly coming off the ceiling.No injury reported.
Additional Manufacturer Narrative
Ref.Id: (b)(4).It was reported that the ceiling suspension had almost come loose from the ceiling rails.Philips field service engineer investigated on site.The ceiling suspension had been hooked back into the ceiling rails by a 3rd party service provider.New catch and brake fitted.The movement was tested and the geometry calibrated.End stops checked, all was ok.The investigation is still ongoing on this event.When the investigation is completed a follow-up report will be sent to the fda.
Additional Manufacturer Narrative
Ref.Id: (b)(4) the digitaldiagnost is a stationary x-ray system for general radiographic purposes.The ceiling suspension (cs) carrying the x-ray tube allows a wide range of longitudinal, transversal and vertical movements in the room.Cs is supported on four metal ball bearings which rolls over longitudinal rails.Operational end stops and additional safety end stops are provided on both sides of longitudinal rails to stop the cs moving beyond it and to avoid derail from longitudinal rails.In case of cs derailing from longitudinal rails the system will lose contact from 2 bearings and will get supported by magnetic brake bracket.Nevertheless the cs will be supported on 3 points.After tilting catch bracket will support cs on other side.Thus at any point of time cs is supported on minimum 3 points and it will not fall from rails.The digitaldiagnost system was relocated from one clinical room into a new room for the customer.As part of this the contractor was working with philips field service engineer (fse) to complete the de- and re-installation of the system.After completion of the reinstallation, it was reported that the cs came off the rails and was hanging down a little.Philips fse investigated on site and found that the safety stops had not been fitted.The cs had been hooked back into the ceiling rails by a 3rd party service provider.New catch and brake fitted.The movement was tested and the geometry calibrated.End stops checked, all was ok.Finally, the system meets the specification for the performed service and is returned to use.Risk estimation revealed no unacceptable risk.The issue is further monitored and trended.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 4.1 CHEST / EMERGENCY
• Common Device Name: SYSTEM, X-RAY, STATIONARY
• 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: 17555052
• Report Number: 3003768251-2023-00047
• Device Sequence Number: 19739681
• Product Code: KPR
• UDI-Device Identifier: 00884838074521
• UDI-Public: 00884838074521
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K210692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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
• Operator of Device: Health Professional
• Device Model Number: 712033
• Device Catalogue Number: 712033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Supplement Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown