• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE Back to Search Results
Catalog Number 5000-01-02
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2021
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 arctic sun device did not rewarm while treating the patient. The patient passively rewarmed and was not controlled by the device. As per follow up information received on 28 oct 2021, the representative could not see any evidence in relation to arctic sun device if it was not automatically rewarming after 24 hours at target temperature. The user assumed that the normothermia mode had been selected rather than the hypothermia mode, and the target temp was adjusted to 36 degrees. Therefore, considering that this mode would not rewarm after 24 hours. It would also appear that on certain instances the therapy had been stopped earlier than 24 hours, prior to when the device would be automatically rewarmed. From reviewing the data, the user believed that the additional training was required.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN® 5000
Type of DeviceARCTIC SUN DEVICE
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 Key12868720
MDR Text Key283181764
Report Number1018233-2021-07513
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 11/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5000-01-02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2021
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: 11/24/2021 Patient Sequence Number: 1
-
-