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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 Problem Device Alarm System (1012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Event Description
It was reported that the arctic sun device had stopped therapy with a large red box six times since the previous night. Nurse claimed that there were no options to close the alarm and that it directed the nurse to turn the machine off and on and there were no numbers on the alarm. Nurse stated that the alarm continued to come back after turning machine off or on. Also stated that event log showed the alert 116 (patient temperature 1 change not detected), alert 03 (water reservoir low), alarm 14 (patient temperature 1 probe out of range), alert 105 (cool patient end) and only one probe in place (foley). Mss suggested to look at the system alarms. And the device gave a new alarm (79 - non-recoverable system error - primary and secondary outlet water temperature sensors differ by greater than 1°c. ). Mss confirmed this was the alarm in the system section of the event log. Mss stated that this machine would need to be sent to the biomed. Nurse confirmed that they had a new machine.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
Event Description
It was reported that the arctic sun device had stopped therapy with a large red box six times since the previous night. Nurse claimed that there were no options to close the alarm and that it directed the nurse to turn the machine off and on and there were no numbers on the alarm. Nurse stated that the alarm continued to come back after turning machine off or on. Also stated that event log showed the alert 116 (patient temperature 1 change not detected), alert 03 (water reservoir low), alarm 14 (patient temperature 1 probe out of range), alert 105 (cool patient end) and only one probe in place (foley). Mss suggested to look at the system alarms. And the device gave a new alarm (79 - non-recoverable system error - primary and secondary outlet water temperature sensors differ by greater than 1°c. ). Mss confirmed this was the alarm in the system section of the event log. Mss stated that this machine would need to be sent to the biomed. Nurse confirmed that they had a new machine.
 
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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 Key13527958
MDR Text Key286022483
Report Number1018233-2022-00604
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 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
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 Received06/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2013
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: 02/14/2022 Patient Sequence Number: 1
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