MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL COOLING EXTRA SMALL KIT; ARCTICGEL COOLING KIT

Catalog Number	317-03-02
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
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.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 during the rewarming phase, arctic sun device flow rate was decreased below 0.2-0.3 l/min.Customer did empty pads several times, reconnected all four pads and checked any leakage from pads.But the flow rate did not go up and the alarm number 01 went off.After all the customer's effort, they changed arctic gel pads, and the flow rate was maintained as 1.8-1.9l/min.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.Baw7650745, rev 1, was reviewed for this investigation.The labeling is found to be adequate.The baw is attached on the investigation overview element.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: b, d.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 during the rewarming phase, arctic sun device flow rate was decreased below 0.2~0.3 l/min.Customer did empty pads several times, reconnected all four pads and checked any leakage from pads.But the flow rate did not go up and the alarm number 01 went off.After all the customer's effort, they changed arctic gel pads, and the flow rate was maintained as 1.8~1.9l/min.Per follow up information received via task on 12sep2024, device was sent to gimpo warehouse for the evaluation.The issue was solved by replacing with a new arctic gel pad.Therapy was completed with the original device.

• Brand Name: ARCTICGEL COOLING EXTRA SMALL KIT
• Common Device Name: ARCTICGEL COOLING KIT
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE -1725056; 321 south taylor ave; suite 200; louisville CO 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 20191356
• Report Number: 1018233-2024-05710
• Device Sequence Number: 7113250
• Product Code: DWJ
• UDI-Device Identifier: 10801741080040
• UDI-Public: (01)10801741080040(11)221006(17)240831(10)NGGV3906
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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 Expiration Date: 08/31/2024
• Device Catalogue Number: 317-03-02
• Device Lot Number: NGGV3906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown