MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR

Catalog Number	735-02
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
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.All available udi information is being provided.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.
Event or Problem Description
It was reported that the arctic sun device did not detect the patient's temperature.Per review of wo, no consequence for patient.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction- b, d, h.All available udi information is being provided.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.
Event or Problem Description
It was reported that the arctic sun device did not detect the patient's temperature.Per review of wo, no consequence for patient.Per follow up information received via mail on 12mar2026, the client reported that this console was no longer reaching the required temperature target.They have two consoles in their department.They simply switched devices to continue the therapy.Per sample evaluation results received via task on 20mar2026, it was reported that there were cracks on the level sensor.
Additional Manufacturer Narrative
The reported issue was confirmed.The device was evaluated upon receipt.Defective nellcor temperature cable (no temperature reading).Replaced nellcor temperature cable.Cracks on the level sensor.Replaced level sensor.Added screen protector.Fv-est-ctu calibration was performed and passed.A dhr is not required because the batch number of the product is unknown.The batch number for this product is unknown.The most recent ifu will be reviewed.Corrections made to tab(s) f and h.Udi format updated with available product information per gudid.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.
Event or Problem Description
It was reported that the arctic sun device did not detect the patient's temperature.Per review of wo, no consequence for patient.Per follow up information received via mail on 12mar2026, the client reported that this console was no longer reaching the required temperature target.They have two consoles in their department.They simply switched devices to continue the therapy.Per sample evaluation results received via task on 20mar2026, it was reported that there were cracks on the level sensor.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR
• Common Device Name: TEMPERATURE CABLE
• 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, GA 30014 ; 7707846100
• MDR Report Key: 24594585
• Report Number: 1018233-2026-01713
• Device Sequence Number: 21413947
• Product Code: DWJ
• UDI-Device Identifier: 00801741080296
• UDI-Public: (01)00801741080296
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 04/17/2026

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 Catalogue Number: 735-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Supplement Date Received by Manufacturer: 03/20/2026; 04/17/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/23/2026; 04/21/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown