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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE Back to Search Results
Device Problems Failure to Sense (1559); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2022
Event Type  malfunction  
Event Description
It was reported that the nurse was attempting to initiate hypothermia on the arctic sun device and the temperature probe was not reading. Bladder probe was in place. The device dashes where patient temperature displayed. Nurse made sure the temperature cable was in temperature port 1. Mss explained that this could be from issue with the temperature in cable or the bladder probe. Mss recommended the nurse to change out the temperature in cable first and then the bladder probe if needed. Nurse stated that the bladder probe did read on their overhead screen. Mss also explained how the temperature in cable was removed and would obtain another cable. Per follow up information received via ibc on (b)(6) 2022, nurse stated that they replaced the temperature cable as suggested by mss and was able to complete therapy with no further issues. Nurse also stated there was no impact to patient and old temperature cable was taken by biomed.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
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Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of DeviceTEMPERATURE CABLE
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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key13553253
MDR Text Key285952772
Report Number1018233-2022-00701
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 06/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/17/2022
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: 02/17/2022 Patient Sequence Number: 1
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