MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE PROBE CABLE

Catalog Number	735-02
Medical Device Problem Codes	Defective Component (2292); Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue was isolated to a temp cable failure.The arctic sun 5000 was evaluated onsite.During the evaluation, it was found that the temp cable was faulty.Replaced temp in cable.Device passed all applicable testing.The instructions-for-use are found to be adequate.The ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.A device history review is not required as the serial number is unknown.Corrections: f, g.The complete initial reporter facility name is (b)(6).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 alarm code 113 (reduced water temperature control) and 64 (non-recoverable system error) messages appeared on the screen during therapy today.Per review of wo on 29jan2025, device was used on patient.No patient identifiers available, no patient impact reported.Per follow up information received via mail on 10mar2025, issue resolved onsite.Preventive maintenance was performed correctly and the device worked correctly.Also, the temperature cable nellcor had to be replaced.Per additional information updated in wo on 20may2025, it was reported that there was no visible damage, but if moved it, the temperature would increase and decrease a lot, then it was replaced, because the measure was not correct.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The complete initial reporter facility name is (b)(6) hospital edf.Hospitalization floor -1 pharmacy warehouse.The reported product number is unknown.The udi number for this product is not available.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 alarm code 113 (reduced water temperature control) and 64 (non-recoverable system error) messages appeared on the screen during therapy today.Per review of wo on 29jan2025, device was used on patient.No patient identifiers available, no patient impact reported.Per follow up information received via mail on 10mar2025, issue resolved onsite.Preventive maintenance was performed correctly and the device worked correctly.Also, the temperature cable nellcor had to be replaced.Per additional information updated in wo on 20may2025, it was reported that there was no visible damage, but if moved it, the temperature would increase and decrease a lot, then it was replaced, because the measure was not correct.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The complete initial reporter facility name is (b)(6) hospital.Correction: d, 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 alarm code 113 (reduced water temperature control) and 64 (non-recoverable system error) messages appeared on the screen during therapy today.Per review of wo on 29jan2025, device was used on patient.No patient identifiers available, no patient impact reported.Per follow up information received via mail on 10mar2025, issue resolved onsite.Preventive maintenance was performed correctly and the device worked correctly.Also, the temperature cable nellcor had to be replaced.Per additional information updated in wo on 20may2025, it was reported that there was no visible damage, but if moved it, the temperature would increase and decrease a lot, then it was replaced, because the measure was not correct.

• Brand Name: ARCTIC SUN TEMPERATURE PROBE CABLE
• Common Device Name: TEMPERATURE PROBE 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: 22180026
• Report Number: 1018233-2025-04370
• Device Sequence Number: 15750392
• Product Code: DWJ
• UDI-Device Identifier: 00801741080296
• UDI-Public: (01)00801741080296
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 08/08/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/17/2025; 08/08/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 06/20/2025; 08/13/2025
• 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