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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 Alarm System (1012); Insufficient Heating (1287)
Patient Problems Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
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 the patient was not heating on the arctic sun device. They received alarm 115 (prolonged warm water exposure) and ms&s explained this alarm is a safety alarm and that staff needs to do frequent skin checks. The patient temperature was 94. 5f (34. 7c), rectal and esophageal temperature was 95. 5f (35. 3c). The water temp fluctuated between 105-107f (40-42c) and flow rate was 2. 5l/m. Patient weighed 65 kg and was using a size small arctic gel pad. Patient had no exposed abdomen, a bair hugger was applied and the patient was administered with propofol. They have been trying to warm patient for 12 hours. Ms&s had advised the complainant to continue to do skin checks and restart therapy if appropriate as the alarms do stop the therapy. Per follow-up on (b)(6) 2020 with nurse (b)(6), she confirmed patient was able to reach warming temperature after consulting with the doctor and adding blankets and a vent warmer. Per nurse, the propofol was administered per protocol, not in response to therapy. No further issues. Patient is maintaining target temperature. No further follow ups needed at this time.
 
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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 Key10448031
MDR Text Key209213529
Report Number1018233-2020-05424
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? No
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 Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2013
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: 08/25/2020 Patient Sequence Number: 1
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