MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. INGENUITY CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	INGENUITY CORE 64
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	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The internal ring cover came loose from a damaged rotating internal component and caused a patient to experience a superficial cut to their left elbow with slight bleeding.The cut was treated with a bandage.Patient outcome is listed as a bruise expected to fully heal, no pain and full functionality of the elbow/arm.Therefore, the reported harm does not meet criteria for serious injury.However, it is uncertain whether this event is likely to recur and cause a serious injury.Therefore, based on the available information this issue has been determined to be a reportable event.Philips has started an investigation of this complaint.
Additional Manufacturer Narrative
It has been reported to philips that, the internal ring cover came loose from a damaged rotating internal component and caused a patient to experience a superficial cut to their left elbow with slight bleeding.The cut was treated with a bandage.Patient outcome is listed as a bruise expected to fully heal, no pain and full functionality of the elbow/arm.A philips field service engineer (fse) has replaced the faulty parts and conducted the necessary calibration, restoring the system to good working order.Based on the risk assessment, it has been determined that the reported malfunction, if it were to recur, would not be likely to cause or contribute to a death or serious injury.Therefore, this event has been determined not to be a reportable event.
Event or Problem Description
The internal ring cover came loose from a damaged rotating internal component and caused a patient to experience a superficial cut to their left elbow with slight bleeding.The cut was treated with a bandage.Patient outcome is listed as a bruise expected to fully heal, no pain and full functionality of the elbow/arm.- philips has completed the investigation of this event.

• Brand Name: INGENUITY CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: estelle hilas ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 20044338
• Report Number: 3015777306-2024-00008
• Device Sequence Number: 7933821
• Product Code: JAK
• UDI-Device Identifier: 00884838059498
• UDI-Public: (01)00884838059498(21)40081
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160743
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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: INGENUITY CORE 64
• Device Catalogue Number: 728321
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 08/05/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2021
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Weight: 90 KG