MAUDE Adverse Event Report: IQON SPECTRAL CT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	728332
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: 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 (b)(4).
Event or Problem Description
The complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was that the customer entered the patient weight in pounds, but the p3t (personalized patient protocol) calculation for the required contrast amount was given for the patient weight in kilograms, doubling the contrast dose.Based on the available information, this issue has been initially determined to be a reportable event.
Event or Problem Description
The complaint has been evaluated based on the information provided; there is no allegation of death or serious injury.The issue reported was that the customer entered the patient weight in pounds, but the p3t (personalized patient protocol) calculation for the required contrast amount was given for the patient weight in kilograms, doubling the contrast dose.Based on the available information, this issue has been initially determined to be a reportable event.
Additional Manufacturer Narrative
The customer uses syncright p3t (personalized patient protocol) to calculate the required contrast amount for each patient.After a software upgrade, the user changed the weight preference settings on the patient demographics page to pounds (lbs), as this is an option.The user manually entered the patient weight in pounds, but the calculation for the contrast amount was given in kilograms (kg).This resulted in an increased amount of contrast volume recommended for the patient.It was confirmed that the patient received a double dose of contrast, however, no injuries or harm was reported.A philips field service engineer (fse) reported to the site to evaluate the system and confirmed the reported issue.The fse reset the patient weight preference and changed the weight input from pounds to kilograms.The injection rate was then properly calculated and subsequent scans operated normally.Engineering concluded that the software failure only occurs when the user selects the weight unit to be configured in pounds.The trained healthcare professional is required to confirm that all injection values are acceptable prior to scanning a patient.The injection values are displayed on both the injector and the console p3t ui (user interface).The trained healthcare professional should be able to detect the if the amount of contrast is higher due to the conversion of patient body weight, and the system requires the operator to confirm the recommended dosage before pressing the ok.The probable cause: software failure to convert patient weight units according to injector interface specification.Internal cross reference: (b)(4).Health impact code: c50675- no health consequences or impact.Date of report: 20210604.

• Brand Name: IQON SPECTRAL CT
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• MDR Report Key: 11602878
• Report Number: 3015777306-2021-10000
• Device Sequence Number: 19732702
• Product Code: JAK
• UDI-Device Identifier: 00884838059542
• UDI-Public: 00884838059542
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K193454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• 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: 728332
• Device Catalogue Number: 728332
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 03/11/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 06/04/2021
• 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