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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS ARCTICGEL PADS Back to Search Results
Catalog Number 317-07
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/04/2022
Event Type  malfunction  
Event Description
It was reported that they had a patient on arctic sun device who was cooled after an initial insult. Patient had now been rewarmed and was maintaining at normothermia. Nurse stated that the target temperature was 37c, this morning the patient was 37. 2c, currently the patient temperature was 36. 5c, water temperature was 31. 6c. Nurse wanted to confirm that the device was working properly. Nurse did not understand why the water temperature was lower than the patient temperature if the patient was below target. Nurse stated that the trend was neutral, heater command was 12 percent, pump hours were 6923, system hours were 7797, flow rate was 2. 7lpm, inlet pressure was -7psi, patient weighs 83kg, medium pads were in place. Nurse stated that pads had been on for 4 to 5 days and were not adhering well at this point. Nurse stated that foley probe was in place. There was some exposed abdomen. Mss explained that the device was responding appropriately. There was a 0. 5c allowable tolerance. Mss explained 12 percent of heater command, and that if the water was a lot warmer the patient would rewarm too quick and potentially above 37c. Mss suggested seeing how long the patient would be on therapy and replaced the pads as needed.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Type of DeviceARCTICGEL 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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key15051946
MDR Text Key303815242
Report Number1018233-2022-05593
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number317-07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/19/2022 Patient Sequence Number: 1
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