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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 Cooling (1130); Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2022
Event Type  malfunction  
Event Description
It was reported that nurse had a patient cooling on arctic sun device around 1am on (b)(6) 2022. Nurse stated that the device was sounding alert 113 (reduced water temp control), patient temperature was 32. 5c, water temperature was 29. 8c, flow rate was 3. 1l/min, target temperature was 33c, reservoir level was 5 and heater command was 0 percent. Mss walked the nurse through draining 500 mls of water from the right drain port. Nurse stated that the water did not initially drain so they reversed the fill tubing, fine sediment initially came out and then the water cleared and started to flow out. At around 11pm, it was further reported that the hypothermia patient was cooling on arctic sun device with 1 hour left before rewarming began. Nurse reported that the device had been giving alert 113 (reduced water temp control) again this evening. Last night device was giving same alarm and 500 mls of water was drained. Nurse stated that the device worked fine all day but tonight the device is giving alert 113 (reduced water temp control) again, patient temperature was 32. 9c, water temperature was 30. 8c, flow rate was 3l/min, target temperature was 33c. Mss recommended nurse to change out the device and label this one with alert 113 (reduced water temp control) and send this one for repair. Nurse had another device available. Mss explained that nurse needed to empty the pads into this device before changing to the new device.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC 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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13642741
MDR Text Key286674860
Report Number1018233-2022-00978
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,Followup
Report Date 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
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
Date Manufacturer Received06/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2015
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: 03/01/2022 Patient Sequence Number: 1
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