MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTICGEL PADS

Model Number	31801
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
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.The device was not returned.
Event or Problem Description
It was reported that the patient currently on arctic sun device with one small universal pad connected.Weight of patient was too small for xxs pads which was the smallest size they currently have.Patient has been on therapy for 5 days now.It was maintaining temperature and cooling the patient, but the last 2 days patient did not seem to be cooling.Patient weight 12 kilograms.Been alerting low flow.Mis explained for patient weight recommended pad application would be 3 small universal pads.Wrap 2 pads loosely around chest and abdomen.Add a third pad around the legs.Nurse stated they have no more universal small pads.Flow rate was 0.4 lpm.Mis discussed importance of flow rate for functionality.Nurse has a set of xxs arctic gel pads nurse would connect to boost flow rate.Emailed pediatric pad size qrgs.
Event or Problem Description
It was reported that the patient currently on arctic sun device with one small universal pad connected.Weight of patient was too small for xxs pads which was the smallest size they currently have.Patient has been on therapy for 5 days now.It was maintaining temperature and cooling the patient, but the last 2 days patient did not seem to be cooling.Patient weight 12 kilograms.Been alerting low flow.Mis explained for patient weight recommended pad application would be 3 small universal pads.Wrap 2 pads loosely around chest and abdomen.Add a third pad around the legs.Nurse stated they have no more universal small pads.Flow rate was 0.4 lpm.Mis discussed importance of flow rate for functionality.Nurse has a set of xxs arctic gel pads nurse would connect to boost flow rate.Emailed pediatric pad size qrgs.
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.H3 other text : the device was not returned.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Common Device Name: ARCTICGEL PADS
• 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: 16029274
• Report Number: 1018233-2022-09761
• Device Sequence Number: 20244622
• Product Code: DWJ
• UDI-Device Identifier: 00801741080128
• UDI-Public: (01)00801741080128
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K142702
• 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): 04/04/2023

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: 31801
• Device Catalogue Number: 318-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Weight: 12 KG