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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 NELLCOR ARCTIC SUN TEMPERATURE CABLE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR ARCTIC SUN TEMPERATURE CABLE Back to Search Results
Model Number 73502
Device Problems Failure to Sense (1559); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  malfunction  
Event Description
It was reported that the normothermia patient was on dyzj059 with a target of 36 c. The nurse reported that the arctic sun device suddenly stopped displaying the patient temperature. They had a foley connected to the arctic sun device and switched to the esophageal probe, neither displayed. The temperature displayed in the overhead monitor pt
=
35. 6c, wt
=
30c, fr
=
3. 4l/min. They flexed the temperature in cable and got a temperature reading briefly and switched out the temperature in cable with the new cable and the temperature was displayed. Temperature cable was labeled (b)(4).
 
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® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR
Type of DeviceARCTIC SUN 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 Key12981738
MDR Text Key286515466
Report Number1018233-2021-07971
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080296
UDI-Public(01)00801741080296
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number73502
Device Catalogue Number735-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2022
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: 12/12/2021 Patient Sequence Number: 1
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