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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCITCSUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCITCSUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Device Alarm System (1012); Device Sensing Problem (2917); Temperature Problem (3022)
Patient Problems Seizures (2063); Patient Problem/Medical Problem (2688)
Event Type  Injury  
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 patient was below the target temperature while on the arcticsun device. The patient was set to rewarm from 36. 5c, and the device was alarming 115 (prolonged warm water exposure). The water temperature was 39c, the flow rate was 1. 1l/min, the baby was in a 'nest', the radiant heat was 10%, and the trend was pointing down. The nurse was advised to increase the radiant heat. The nurse was called back an hour later and stated that the radiant heat was increased and the patient reached the 36. 5 target temperature. Additional information was received on 09dec2019 from the nurse who stated the baby was seizing while on the device, and phenobarbital and keppra was administered. Once they increased the radiant heater, the patient was able to reach target and complete therapy.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCITCSUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key9497982
MDR Text Key178589781
Report Number1018233-2019-08121
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 health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number50000000E
Device Catalogue Number50000000E
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 Received02/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2019
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: 12/19/2019 Patient Sequence Number: 1
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