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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCTICSUN DEVICE Back to Search Results
Model Number 50000000E
Device Problems Insufficient Heating (1287); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Paralysis (1997); Alteration In Body Temperature (2682)
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 baby was not heating on the arctic sun device. Last night pad was soiled so they changed it. Since then they got an alert 02 on the device and the baby was below target temperature (37c). Ms&s asked what the flow number were and the nurse stated 1. 1-1. 5lpm. Ms&s told that the flow was acceptable for neonate pads. Complainant documented that patient temperature twice as 33c and the water was 29c for the first and as 36c and the water was 34c for the second. Ms&s had the nurse check the graph and the patient temperature with another source. The nurse stated the baby was paralyzed, with no warmers on, or infections. Then nurse stated there was surface counter-warmers on and that the vent circuit was set to 37c. Ms&s asked to turn off the counter-warmers. The nurse could not turn down the vent circuit. Ms&s asked to call in an hour if still concern for patient not being at goal. Per follow up, the biomed could not locate the device.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTICSUN 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 Key10095968
MDR Text Key193297321
Report Number1018233-2020-03485
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received07/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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