MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, CALIBRATION TEST UNIT

Model Number	74100
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the calibration testing unit has the wrong calibration label on it.It was marked as serial number (b)(4) when opened the inner label was serial number (b)(4).
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be due to operator error.However, this could not be confirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the entire test and calibration process takes approximately 90 minutes.Operator assistance is required only in certain stages: ¿ stage 1: warm-up, flow check, and inlet pressure calibration: 12 minutes, automatic.¿ stage 2: patient temperature calibration: 5 minutes, operator assistance required.¿ stage 3: water temperature calibration: 18 minutes, operator assistance required (at completion).¿ stage 4: water temperature calibration, heater check: 33 minutes, operator assistance required (at completion).¿ stage 5: temperature out calibration: 25 minutes, operator assistance required (at completion).Initiating a calibration or test.A.Replace the fluid delivery line with ctu.B.Connect the blue circular connector labeled ¿pt1¿ to the connector patient temperature 1 (larger thermometer and patient symbol).C.Connect the blue circular connector labeled ¿pt2¿ to the connector patient temperature 2 (smaller thermometer and patient symbol).D.Connect the black circular connector labeled ¿to¿ to the connector labeled ¿temp out¿.E.Power on the arctic sun® temperature management system control module.F.Press the advanced setup button on the therapy selection screen.G.Press the start button next to calibration on the advanced setup screen.H.Select sensor calibration to perform a calibration or calibration check of the arctic sun® temperature management system.I.Adjust the values a to h on the ctu calibration screen to match the values on the ctu label.Press continue when complete.J.Select either new calibration or check calibration and follow the on-screen instructions." h11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the calibration testing unit has the wrong calibration label on it.It was marked as serial number (b)(6) when opened the inner label was serial number (b)(6).

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, CALIBRATION TEST UNIT
• Common Device Name: CALIBRATION TEST UNIT
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16732359
• Report Number: 1018233-2023-02528
• Device Sequence Number: 15164421
• Product Code: DWJ
• UDI-Device Identifier: 00801741080418
• UDI-Public: (01)00801741080418
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2023

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: 74100
• Device Catalogue Number: 741-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2010
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown