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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 UNKNOWN TEMPERATURE CABLE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE UNKNOWN TEMPERATURE CABLE Back to Search Results
Device Problem Device Sensing Problem (2917)
Patient Problems No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/28/2021
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 temperature probe was connected to temperature port 1 and temperature port 2 using the same temperature-in cable, and the temperature would not display on arctic sun device (sn: (b)(4)). Mss suggested connecting probe to bedside monitor to see if temperature would display. However, they did not have a compatible cable at this time. Mss suggested speaking with biomed and other departments that utilize arctic sun to see if anyone had a spare temperature-in cable (2 pin round plug, (b)(4)). Mss explained that either the cable or probe will need to be replaced. Local tm contacted the customer and mentioned that they were all set now.
 
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Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of DeviceUNKNOWN TEMPERATURE 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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key11349268
MDR Text Key232575170
Report Number1018233-2021-00669
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 company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2021
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: 02/19/2021 Patient Sequence Number: 1
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