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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 Problems Circuit Failure (1089); Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2021
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 received an alarm 78 on bedside. Mss explained this was indicative of a shorted chiller temperature (t4) thermistor and requested the pricing for ordering it onsite or shipping it back and would make a determination later.
 
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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 Key11862874
MDR Text Key252011071
Report Number1018233-2021-02950
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 Physician Assistant
Type of Report Initial,Followup
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
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 Manufacturer05/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2019
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: 05/21/2021 Patient Sequence Number: 1
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