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 Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

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.

Event Description

The customer reported that the tilting patient platform on the patient support for stitching drops to the floor too fast.No injury reported.

Manufacturer Narrative

Ref.Id: (b)(4).The digital diagnost (didi) c90 is a digital x-ray system used for radiographic imaging.The system supports dedicated examinations like 'stitching', means a combination of a number of images to one image (i.E.For displaying legs of a patient as one image).A patient support for stitching will be used to support such examinations.The patient has to step onto a foldable flap prior the examination.Our investigation did not reveal any defects on the patient support for stitching.The complaint was filed as an impression that the didi c90 stand seems to move faster.No allegations of person harm are made.No correction required.System works as specified.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.Correction: h6 result and conclusion.

• 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 ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14168904
• MDR Text Key: 289776511
• Report Number: 3003768251-2022-00004
• Device Sequence Number: 1
• Product Code: MQB
• UDI-Device Identifier: 00884838090699
• UDI-Public: 00884838090699
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 712034
• Device Catalogue Number: 712034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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