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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 Therapeutic Effects, Unexpected (2099); No Consequences Or Impact To Patient (2199)
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 rewarming too quickly. The nurse stated the patient warmed 2c/hr and the device was set at a rate of 0. 25c/hr. Per troubleshooting, the water was in the 7c range. The nurse was advised that the device was actively slowing the rewarm process and that this issue may be patient related. Per follow up, charge nurse stated the device was not in use at that time and was still on the floor. It was not know if therapy was able to be completed.
 
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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 Key10092218
MDR Text Key193651282
Report Number1018233-2020-03403
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2020
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 Received07/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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