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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 Problem Device Sensing Problem (2917)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
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 was not reading on arctic sun device. Patient had been transferred up from emergency department (ed) and the arctic sun device had been used there. Confirmed that temperature cable in proper outlet and nurse had tried connecting to rectal and esophageal probes and neither one would work. Explained that if temperature cable was in the correct outlet and not reading with two different probes then confirmed the problem was from the temperature cable. Nurse asked how to override the temperature to use device and explained that arctic sun device could not be used without a temperature reading. Also stated that the nurse did not have another arctic sun device. Asked nurse to send temperature cable to biomed to facilitate ordering another cable.
 
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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 Key11387947
MDR Text Key233897506
Report Number1018233-2021-00852
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 health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number73502
Device Catalogue Number73502
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 Received08/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/26/2021 Patient Sequence Number: 1
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