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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 50000000E
Device Problem Insufficient Cooling (1130)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
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 the arctic sun device had no alarm. The nurse was concerned about the patient temperature was not stable and started on normothermia. The patient target temperature was set to 37 c, and the patient temperature started to increase. The nurse stated they noticed shivering and started shiver protocol along with the bair hugger. The nurse decided to place the device in hypothermia mode. At the same time, the nurse noticed water level was low and filled the machine. The target temperature was set to 37 c. The patient temperature was 38. 1 c. The water temperature was 10 c at beginning of call, by end of call the water temperature decreased to 9. 4 c. The water temperature was set at 4 c. The foley probe was in place, second temperature source was correlating. The device was noted to be doing what it should be doing. The nurse would look into tylenol. Per follow up 1 on 04feb2021 via nurse, the patient continuing the therapy at a controlled rewarm. The medications were given as per the facility's shiver protocol for when the patient needs the control of movements on the device. The nurse did not have the medication list available.
 
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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
MDR Report Key11378738
MDR Text Key234788693
Report Number1018233-2021-00807
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
Combination Product (y/n)N
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2019
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: 02/25/2021 Patient Sequence Number: 1
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