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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE Back to Search Results
Catalog Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2021
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 a hypothermia patient rewarming on the arctic sun device. Nurse reported that the device sounded alarm 80 (non recoverable system error- the control processor failed to detect a simulated water temperature fault). This occurred once and nurse reported that the patient was rewarming too fast. Nurse already cycled the power and the alarm had not reoccurred. Nurse also stated that there were issues yesterday with the temperature in cable. The event log was checked and there was one alert 52 (extended period of cold water. The circulating water temperature has been below 10°c (50°f) for 8 of the previous 10 hours). Mss discussed causes of heat generation and nurse stated there was no more obvious signs of seizure activity, but the patient was warming too fast. Patient temperature was 35c, water temperature was11c and flow rate was 2. 4lpm. Rewarm rate read to rewarm from 34c at 0. 15c/hour to 36. 5c. Nurse had removed the bair hugger which was used for counter warming during the night. Mss explained about alert 52 and recommended the nurse to be diligent with skin checks and to peel the pads back very slowly. Mss explained about extended periods of cold-water delivery that might increase the risk for skin injury. Mss also explained that the water was staying cold because the patient was generating heat and recommended the nurse to discuss this with the care team. Mss advised to assess patient¿s skin underneath the arctic gel pads regularly and recommended to change out the device if alarm 80 reoccurred.
 
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Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of DeviceTEMPERATURE CABLE
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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13023433
MDR Text Key285486091
Report Number1018233-2021-08165
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 Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/16/2021 Patient Sequence Number: 1
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