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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 Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2022
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 got low water alert 03 (water reservoir low), so the device was filled. Nurse called because water temperature was higher that it had been and it was in the 20s. Nurse stated that the event log showed alert 114 (treatment stopped), alert 112(confirm return to cooling phase), and alert 03 (water reservoir low). Nurse stated that current water temperature was 35. 9c, target temperature was 35. 5c, patient temperature was 33. 2c and neonate pad flow rate was 1. 6 l/m. Mss told the nurse to do nothing since patient was at goal and to call back if needed. Per follow up information received via phone on 02feb2022, nurse stated that the therapy was completed with no impact to the patient because baby was at goal temperature. Nurse stated that the arctic sun device continued to shut down on its own and was not functioning properly. Nurse stated that the arctic sun device was not sent to the biomed.
 
Event Description
It was reported that the arctic sun device got low water alert 03 (water reservoir low), so the device was filled. Nurse called because water temperature was higher that it had been and it was in the 20s. Nurse stated that the event log showed alert 114 (treatment stopped), alert 112(confirm return to cooling phase), and alert 03 (water reservoir low). Nurse stated that current water temperature was 35. 9c, target temperature was 35. 5c, patient temperature was 33. 2c and neonate pad flow rate was 1. 6 l/m. Mss told the nurse to do nothing since patient was at goal and to call back if needed. Per follow up information received via phone on 02feb2022, nurse stated that the therapy was completed with no impact to the patient because baby was at goal temperature. Nurse stated that the arctic sun device continued to shut down on its own and was not functioning properly. Nurse stated that the arctic sun device was not sent to the biomed.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13590661
MDR Text Key286055280
Report Number1018233-2022-00838
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 02/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2022
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 Received02/02/2022
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 Treatment Data
Date Received: 02/24/2022 Patient Sequence Number: 1
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