• 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® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS ARCTIC GEL PADS

  • 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® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS ARCTIC GEL PADS Back to Search Results
Model Number 31709
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2021
Event Type  malfunction  
Event Description
It was reported that hypothermia patient started therapy on the arctic sun device 30 minutes ago. Nurse stated that device was sounding alert 01 (patient line open) and displaying low air leak. Target temperature was 36c, patient temperature was 37c, water temperature was 7. 1c and flow rate was 0lpm. Four large arctic gel pads and one universal pad were in place. The device was restarted, and it started to prime, and the flow rate immediately went to 0lpm. System diagnostics water control showed that flow rate was 0lpm, inlet pressure was -0. 4psi and circulation pump command was 100 percent. Nurse reported that one of the chest pads has peeled blue foam and the plastic pad tubing came loose and they reconnected it. Mss explained that the device must be sealed. Mss also recommended to change the pads and if the flow rate remained low, device had to be changed.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The device was not returned.
 
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 hypothermia patient started therapy on the arctic sun device 30 minutes ago. Nurse stated that device was sounding alert 01 (patient line open) and displaying low air leak. Target temperature was 36c, patient temperature was 37c, water temperature was 7. 1c and flow rate was 0lpm. Four large arctic gel pads and one universal pad were in place. The device was restarted, and it started to prime, and the flow rate immediately went to 0lpm. System diagnostics water control showed that flow rate was 0lpm, inlet pressure was -0. 4psi and circulation pump command was 100 percent. Nurse reported that one of the chest pads has peeled blue foam and the plastic pad tubing came loose and they reconnected it. Mss explained that the device must be sealed. Mss also recommended to change the pads and if the flow rate remained low, device had to be changed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
Type of DeviceARCTIC GEL PADS
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 Key13225727
MDR Text Key285408997
Report Number1018233-2021-08754
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080104
UDI-Public(01)00801741080104
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number31709
Device Catalogue Number317-09
Device Lot NumberNGFW3864
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2021
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: 01/11/2022 Patient Sequence Number: 1
-
-