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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 Problems Device Displays Incorrect Message (2591); Device Sensing Problem (2917)
Patient Problems Urinary Tract Infection (2120); Inadequate Pain Relief (2388); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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 Description
It was reported that the patient was not maintaining the hypothermia target temperature on the arctic sun device. The patient's temperature was 36. 4c, the target temperature was 33c, the water temperature was 5. 9c, and the flow rate was 1. 7l/min. There was a foley probe in use with no secondary probe. Therapy had began the previous morning. There were large pads in place, and ms&s recommended adding a universal pad. The nurses stated that the abdomen was adequately covered and refused to add a universal pad. The event log had shown an alert 02 for low flow earlier in the day. The patient was sedated but not paralyzed per the doctor's orders. The nurses denied visible shivering. The patient was in a neck brace, so the nurses were unable to check for microshivering. A urine culture was being done at the time to check for uti. An eeg was in use, showing some activity. It was unclear if the patient was seizing, but the nurses saw no jerking or outward indication of seizing. One nurse mentioned the patient posturing. The nurse stated she would speak with the doctor regarding paralyzing the patient. Ms&s reminded the nurses to be diligent with skin checks. Per follow up with the nurse via phone on 14jun2019, the patient was given a small amount of a paralytic for heat generation. The urine culture had come back positive for urinary tract infection, which the nurse stated was adding to the heat generation. The patient had since reached the target temperature and completed therapy with no further issues.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key8754748
MDR Text Key149839548
Report Number1018233-2019-03533
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
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: 07/02/2019 Patient Sequence Number: 1
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