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

Model Number	INGENUITY ELITE 128
Medical Device Problem Codes	No Device Output (1435); Failure to Calibrate (2440)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/05/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
We have not completed our investigation of this event.We will file a follow-up emdr at the completion of the investigation.Internal cross reference: complaint pr # (b)(4).Date of report: 2021-10-14.
Event or Problem Description
This complaint has been evaluated based on the information provided.The issue reported was that during a head/ neck ct angio exam, the system had an error and would not expose.The customer stated they stopped the patient scan.The customer has alleged that this resulted in a delayed rescue resulting in the patient's death approximately 20 days later.Based on the available information, this issue has been initially determined to be a reportable event and is currently under investigation.
Additional Manufacturer Narrative
Corrections: added the health impact code to the health impact grid updated the "type of reported complaint" to death.This was marked on the follow up report as "product problem" in error.Internal cross reference: complaint (b)(4).Date of report: 20211130.
Additional Manufacturer Narrative
The issue reported was that during a head/neck ct angio exam, an error occurred and the system failed to expose.The customer stated that they stopped the patient scan and alleged that this resulted in a delayed rescue resulting in the patient's death approximately 20 days later.A philips field service engineer (fse) reported to the site to evaluate the reported issue.The fse reviewed logfiles from the system and found kpm&apm over current fault errors, and, filament calibration had not been performed on a regular basis for over a year.The fse performed filament calibration to resolve the issue and the system returned to specification for clinical use.The philips medical affairs officer and clinical validation specialist reviewed all of the information regarding this event.After evaluating the event details, it was confirmed that the ct failure was not considered to have contributed directly, and, most likely not even indirectly to the patient's death.The probable cause: apm/cpm over current due to filament calibration not performed on the recommended regular basis.Internal cross reference: complaint (b)(4).Health impact code: c28554 - the cessation of life.Date of report: 20211112.

• Brand Name: INGENUITY CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; veenpluis 4-6; best 5684 PC; NL 5684 PC
• Manufacturer Contact: crystal dean ; 100 park avenue, suite 300; orange village, OH 44122
• MDR Report Key: 12632486
• Report Number: 3015777306-2021-10012
• Device Sequence Number: 11618361
• Product Code: JAK
• UDI-Device Identifier: 00884838059504
• UDI-Public: 00884838059504
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: INGENUITY ELITE 128
• Device Catalogue Number: 728323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 10/07/2021; 10/07/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/12/2021; 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 62 YR
• Patient Sex: Male