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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 Insufficient Heating (1287); Temperature Problem (3022); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Seizures (2063); Tachycardia (2095); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
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. The patient was cooling below the target temperature (33c). The patient temperature got as low as 31. 8c. The water temperature was in 28-29c range. The nurse turned off the arctic sun device because the patient became hypotensive and bradycardic. Ms&s had turned back on the arctic sun device and the water temperature was 28c at first but went up to 39c. Event log showed alert 11 (the patient temperature 1 below low patient alert ) and alarm 14 (patient temperature 1 probe out of range). Hours ago it showed alert 44 (invalid system log entry) and alert 45 (ac power lost). Nurse stated that flow was good before turned device off and was in 3s after restarting. Ms&s had confirm position of rectal probe and during confirmation, the patient was having a seizure. Nurse called and stated patient was at goal (33c) and the water temperature were in the high 30s. The patient had recently received ativan for seizure. Nurse called again and patient temperature was 32. 8c and the water temperature was 24-28c. The flow rate was good and there were no events in the log. The patient was not shivering, seizing, or infected. Nurse stated patient was breathing higher than set limit. Ms&s had confirm that warmer on vent was off and suggested change of probe to esophagus. Nurse called back and stated that they needed another arctic sun device. Ms&s asked nurse to notify the supervisor to see if one could be borrowed from a neighboring hospital.
 
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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 Key10476953
MDR Text Key205361232
Report Number1018233-2020-05591
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,Followup
Report Date 03/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
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 Received03/04/2021
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: 09/01/2020 Patient Sequence Number: 1
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