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

Model Number	74100
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the calibration test unit failed initial electrical safety testing, requiring the heater harness to be replaced which was due to an unknown failure in the heater harness.The root cause was due to the calibration of the unit had expired.Per sample evaluation results received on 20-jan-2023, the root cause of the reported issue was a failed heater power harness.It was stated that during flow calibration of the unit, it exhibited low flow, which required the manifold to be replaced.It was stated that the power entry module needed to be replaced due to preventative maintenance.It was noted that the heater power harness, manifold, and power entry module were replaced.
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 test unit failed initial electrical safety testing, requiring the heater harness to be replaced which was due to an unknown failure in the heater harness.The root cause was due to the calibration of the unit had expired.Per sample evaluation results received on (b)(6) 2023, the root cause of the reported issue was a failed heater power harness.It was stated that during flow calibration of the unit, it exhibited low flow, which required the manifold to be replaced.It was stated that the power entry module needed to be replaced due to preventative maintenance.It was noted that the heater power harness, manifold, and power entry module were replaced.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr is not reportable.H11: section a through f - the information provided by bd represents all 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 bd.

• 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: 16325864
• Report Number: 1018233-2023-00725
• Device Sequence Number: 7828223
• 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): 08/01/2023

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: 74100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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