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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 Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Pneumonia (2011); 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 information provided by bard represents all of 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 bard. The device was not returned.
 
Event Description
It was reported that the patient's temperature was 36. 2c with a target temperature of 36c, but the patient had initially overshot the target temperature to 35. 3c. The water temperature was 21c, the flow rate was optimal and there were no recent alarms. The patient was sedated and paralyzed and was suspected to have pneumonia and neurological fever. It was suggested to use an esophageal probe instead of a bladder probe for better temperature control.
 
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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 Key7584497
MDR Text Key110592266
Report Number1018233-2018-02137
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2018
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/08/2018 Patient Sequence Number: 1
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