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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN 5000 Back to Search Results
Model Number 50000000E
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2021
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 nurse changed the arctic sun device to rewarming mode 4 hours ago, but the patient was cooling instead of warming. Stated that the target temperature was 36c, patient temperature was 35. 1c, they wanted to warm at 0. 25c/hr to 37c, flow rate was good, water temperature was 17c and no alarms in the event log. Nurse had tried to fix it by pushing some buttons and asked others for help before calling the mss. Nurse stated that currently rewarm temperature was 35. 3c, nurse did not recall what it had been earlier. Mss instructed nurse to increase target temperature on cool side since this was probably why patient temperature dropped. Nurse was not able to change the target to higher than 35. 5c. And stated in more menu setting, all were correct. Mss confirmed did not need any information and asked the nurse to push therapy selection and choose new patient. When doing this nurse was able to increase the target temp to 36c. Mss asked nurse to confirm with doctor where they wanted to start rewarming from and doctor said to start from current temperature so adjusted target temperature to 35. 2c with 0. 2c/hr rewarm rate to 37c. Mss was unclear why device cooled patient to 35. 1c but programmed rewarming mode correctly now.
 
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Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC SUN 5000
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 Key12820419
MDR Text Key280897302
Report Number1018233-2021-07262
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 03/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2018
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: 11/16/2021 Patient Sequence Number: 1
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