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

Model Number	DIGITALDIAGNOST 4.1 CHEST / EMERGENCY
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reference id: (b)(4).The digital diagnost 4.X is a stationary x-ray system for general radiographic purposes.For anatomies that are larger than the detector size, it is possible to make a series of exposures covering the whole anatomy (for example full spine or full legs).These individual images can be "stitched" together via the software program.For proper patient positioning and support, the patient can be placed on the so called stitching patient support or stitching stand, a platform with two handles that the patient can hold on to during the examination.For the ease of use during transportation, the patient support for stitching has wheels and a folding footboard.The footboard is connected to the frame via two hinges and a brake cylinder.It has to be folded up and fixed by a hook for transportation, e.G.From one room to another.The brake cylinder introduced to ensure that the footboard lowers itself slowly (within 5-7 seconds) when the hook is released, to prevent the footplate from falling on the foot of a person.If the operator steps on the footboard while it is still moving down, the mounting of the brake cylinder can break and the footboard falls down immediately.In a worst case, it may hit the foot of a person and break a bone.Philips received a complaint on digital diagnost 4.X indicating that the stitching stand hydraulic ram has come loose.The device was not in clinical use, and there was no harm to the patient or user.The remote service engineer (rse) performed analysis and concluded that the reported issue involved the patient stitching support accessory, where the brake cylinder became detached from the base of the stand while the equipment was outside clinical use during cleaning activities.Investigation confirmed that the brake cylinder had come off the base because the mounting area where the brake cylinder screws attach showed signs of wear, which may have reduced the ability to firmly secure the screws.No evidence was identified to indicate that the hydraulic brake itself was defective.At the time of the event, the customer reported that the stitching stand brake had become disconnected from the frame, requiring the base of the stitching stand to be lowered manually.Although this affected normal accessory operation, patient impact was not identified, as the stand could still be manually lowered by the radiographer if stitching was required.The customer also had another patient stitching support available for continued use.During onsite service, the attachment mechanism connecting the brake to the stand was unscrewed, reattached, and secured.Functional testing and verification were subsequently performed and documented in the test and verification report, confirming that the brake operated as intended.Following successful verification, the device was returned to full functionality.Based on the information available and the testing conducted, the cause of the reported problem was wear and tear.The reported problem was confirmed by the customer.
Event or Problem Description
It was reported that the stitching stand hydraulic ram has come loose.The device was not in clinical use, and there was no harm to the patient or user.

• Brand Name: DIGITALDIAGNOST 4.1 CHEST / EMERGENCY
• Common Device Name: 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: 24751380
• Report Number: 3003768251-2026-100004
• Device Sequence Number: 16003508
• Product Code: MQB
• UDI-Device Identifier: 00884838074521
• UDI-Public: (01)00884838074521
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K141736
• 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
• Report Date (Section B): 04/01/2026

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: DIGITALDIAGNOST 4.1 CHEST / EMERGENCY
• 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: 03/16/2026
• Initial Report FDA Received Date: 04/01/2026
• 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