• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE Back to Search Results
Catalog Number 50000000
Device Problems Insufficient Heating (1287); Lack of Effect (4065)
Patient Problem Convulsion/Seizure (4406)
Event Date 07/24/2023
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.
 
Event Description
It was reported that the nurse stated the patient temperature dropped and the arctic sun device alerted the low patient temperature.The patient temperature was 32.6c, target temperature was 33.5c and water temperature was 39.7c.The nurse noted and spoke with representative, they advised to disconnect and reconnect probe and temperature cable but no change.The nurse verified the connection between probe and cable and also between cable and device.Esophageal probe was in use and placement confirmed.Unable to plug probe into bedside monitor or alternate device and secondary probe correlates with the patient temperature at 32.4c.They discussed patient condition and seizure activity that occurred a few minutes before the patient temperature drop.Discussed medications that were administered.They noted device was responding appropriately to patient temperature drop and secondary source confirmed the patient temperature so the drop appears to be patient related.Call back with additional questions/concerns.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.
 
Event Description
It was reported that the nurse stated the patient temperature dropped and the arctic sun device alerted the low patient temperature.The patient temperature was 32.6c, target temperature was 33.5c and water temperature was 39.7c.The nurse noted and spoke with representative, they advised to disconnect and reconnect probe and temperature cable but no change.The nurse verified the connection between probe and cable and also between cable and device.Esophageal probe was in use and placement confirmed.Unable to plug probe into bedside monitor or alternate device and secondary probe correlates with the patient temperature at 32.4c.They discussed patient condition and seizure activity that occurred a few minutes before the patient temperature drop.Discussed medications that were administered.They noted device was responding appropriately to patient temperature drop and secondary source confirmed the patient temperature so the drop appears to be patient related.Call back with additional questions/concerns.
 
Event Description
It was reported that the nurse stated the patient temperature dropped and the arctic sun device alerted the low patient temperature.The patient temperature was 32.6c, target temperature was 33.5c and water temperature was 39.7c.The nurse noted and spoked with representative, they advised to disconnect and reconnect probe and temperature cable but no change.The nurse verified the connection between probe and cable and also between cable and device.Esophageal probe was in use and placement confirmed.Unable to plug probe into bedside monitor or alternate device and secondary probe correlates with the patient temperature at 32.4c.They discussed patient condition and seizure activity that occurred a few minutes before the patient temperature drop.Discussed medications that were administered.They noted device was responding appropriately to patient temperature drop and secondary source confirmed the patient temperature so the drop appears to be patient related.Call back with additional questions/concerns.
 
Manufacturer Narrative
The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause of the reported issue is inadequate pharmaceutical delivery.However, this cannot be confirmed.A dhr review is not required as the serial number is unknown.The instructions for use were found adequate and state the following: "the rate of temperature change and potentially the final achievable patient temperature is affected by many factors.Treatment application, monitoring and results are the responsibility of the attending physician.If the patient does not reach target temperature in a reasonable time or the patient is not able to be maintained at the target temperature, the skin may be exposed to low or high water temperatures for an extended period of time which may increase the risk for skin injury.Ensure that pad sizing/coverage and custom parameter settings are correct for the patient and treatment goals, refer to the arcticgel pad instructions for use for the appropriate flow rate.For patient cooling, ensure environmental factors such as excessively hot rooms, heat lamps, and heated nebulizers are eliminated and patient shivering is controlled.Otherwise, consider increasing minimum water temperature, modifying target temperature to an attainable setting or discontinuing treatment.For patient warming, consider decreasing maximum water temperature, modifying target temperature to an attainable setting or discontinuing treatment." h11: section a through f - the information provided by bd represents all 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 bd.H3 other text: the device was not returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARCTIC SUN® 5000
Type of Device
ARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
suite 200
louisville 80027
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key17571464
MDR Text Key321411640
Report Number1018233-2023-06155
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 Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/24/2023
Initial Date FDA Received08/18/2023
Supplement Dates Manufacturer Received10/06/2023
01/19/2024
Supplement Dates FDA Received10/30/2023
01/22/2024
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 Sequence Number1
Patient Outcome(s) Required Intervention;
-
-