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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000; ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problems Display or Visual Feedback Problem (1184); Device Dislodged or Dislocated (2923); Temperature Problem (3022)
Patient Problems Unspecified Infection (1930); Seizures (2063); Chills (2191)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the arcticsun device displayed an alarm 14.An esophageal probe was in place.The patient's temperature was 36.2c, the target temperature was 35c, and the water temperature was 33.6c.The nurse checked the probe and cable and the esophageal probe was dislodged.The water temperature was at 40c due to the dislodgement.The nurse repositioned the probe and the patient was moving around.The patient was responsive to stimuli and mss discussed causes of heat generation.After an hour, the nurse noted everything was working well.The patient's temperature was at 36.7c, the target was 35c and the water temperature was 9c and the flow rate was 2.7lpm.The patient was not showing signs of shivering.Mss noted that the device was making cold water and the flow rate was optimal which suggested that this was patient-related (seizures, shivering or infectious process).Mss suggested adding a blanket for counter-warming and recommended she spoke to the patient's doctor about this issue.
 
Manufacturer Narrative
Per additional information received, bd has determined that this mdr was initially reported in error as this event is not reportable.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
 
Event Description
It was reported that the arcticsun device displayed an alarm 14.An esophageal probe was in place.The patient's temperature was 36.2c, the target temperature was 35c, and the water temperature was 33.6c.The nurse checked the probe and cable and the esophageal probe was dislodged.The water temperature was at 40c due to the dislodgement.The nurse repositioned the probe and the patient was moving around.The patient was responsive to stimuli and mss discussed causes of heat generation.After an hour, the nurse noted everything was working well.The patient's temperature was at 36.7c, the target was 35c and the water temperature was 9c and the flow rate was 2.7lpm.The patient was not showing signs of shivering.Mss noted that the device was making cold water and the flow rate was optimal which suggested that this was patient-related (seizures, shivering or infectious process).Mss suggested adding a blanket for counter-warming and recommended she spoke to the patient's doctor about this issue.
 
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Brand Name
ARCTIC SUN 5000
Type of Device
ARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key8590352
MDR Text Key144837516
Report Number1018233-2019-02355
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
Combination Product (y/n)N
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Date Manufacturer Received06/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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