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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTICSUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTICSUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bacterial Infection (1735); Pneumonia (2011)
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.
 
Event Description
It was reported that the patient was shivering during arctic sun therapy. The patient was started on arctic sun therapy on (b)(6) 2018. Counter warming measures, including a bair hugger and blankets were implemented for shivering on (b)(6) 2018 until (b)(6) 2018. The patient was treated with acetaminophen/paracetamol, buspirone and meperidine per protocol from initiation of therapy. A chest xray was performed and sputum specimen collected on (b)(6) 2018. The chest xray demonstrated pneumonia and was confirmed by the sputum culture which was resulted on (b)(6) 2018 showing gram stain positive 2+ klebsiella pneumonia subspecies. Antibiotics were given for the pneumonia and discontinued on (b)(6) 2018. The arctic sun therapy was suspended from (b)(6) 2018 at 05:59am for three hours and then resumed at 9:00am, 206 minutes later. The patient was able to complete therapy on (b)(6) 2018.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTICSUN 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 Key7625591
MDR Text Key111895189
Report Number1018233-2018-02369
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 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2016
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: 06/21/2018 Patient Sequence Number: 1
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