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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem Insufficient Cooling (1130)
Patient Problem Chills (2191)
Event Date 01/29/2022
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that a hypothermia patient was cooling on the arctic sun device since 1:57pm. Nurse reported that the device was sounding alert 52 (extended period of cold water). Also reported that the patient did not reach the target temperature until 9:48 pm. The target temperature was 36c, patient temperature was 35. 6c, water temperature was 5. 7c and flow rate was 1. 8lpm. The weight of the patient was noted to be 92kgs and had four large pads in place with good coverage. Mss discussed causes of that alert and heat generation. Nurse stated that the patient had been shivering and reported that the patient was administered with one dose of a paralytic earlier and the shivering temporarily stopped, but then the patient was shivering again. Also explained that the shivering must be controlled or else the water would stay very cold. Nurse noticed the therapy was in normothermia instead of hypothermia. Mss encouraged to follow the shivering protocol and be diligent with skin checks as the water was cold.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that a hypothermia patient was cooling on the arctic sun device since 1:57pm. Nurse reported that the device was sounding alert 52 (extended period of cold water). Also reported that the patient did not reach the target temperature until 9:48 pm. The target temperature was 36c, patient temperature was 35. 6c, water temperature was 5. 7c and flow rate was 1. 8lpm. The weight of the patient was noted to be 92kgs and had four large pads in place with good coverage. Mss discussed causes of that alert and heat generation. Nurse stated that the patient had been shivering and reported that the patient was administered with one dose of a paralytic earlier and the shivering temporarily stopped, but then the patient was shivering again. Also explained that the shivering must be controlled or else the water would stay very cold. Nurse noticed the therapy was in normothermia instead of hypothermia. Mss encouraged to follow the shivering protocol and be diligent with skin checks as the water was cold.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC SUN DEVICE
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 Key13588834
MDR Text Key286337086
Report Number1018233-2022-00828
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
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 07/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/23/2022 Patient Sequence Number: 1
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