• 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 PAD NEONATAL

  • 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 PAD NEONATAL Back to Search Results
Catalog Number 318-02
Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Skin Discoloration (2074); Skin Irritation (2076); Skin Tears (2516); Superficial (First Degree) Burn (2685)
Event Date 05/05/2020
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 arctic sun device had low flow during normothermia. The flow rate ranged from 0. 8-1. 0 lpm. The complainant noted that the patient developed skin lesions on the back of the head. No medical intervention reported. Additional information was received via ibc via email that the clinical staff performed pressure-relief techniques by performing more consistent short-interval positioning. Arctic sun therapy was also discontinued to avoid possible severe traumatic brain injury. The wound was exposed and regularly reevaluated and assessed. Clinical evaluation of photo: a localized, circular-shaped , purple colored, intact wound to the occiput was noted. The wound appeared well demarcated, with no visible edema or exudate. The skin surrounding the wound was slightly erythematous. Clinical evaluation of photo: a localized, circular shaped wound was noted with various discolorations: center was light tan surrounded by some erythema and pink colored tissue. There was no visible edema or exudate. Hair was apparent throughout the wound area. Per additional information received from the ibc , no ointments or medications were applied to the wound. The wound was reported to be healing and a foam dressing was recommended, but not "sensical" as the patient was "agile. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
Type of DeviceARCTIC GEL PAD NEONATAL
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 Key10091597
MDR Text Key192179636
Report Number1018233-2020-03360
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number318-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated by Manufacturer? Yes
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: 05/27/2020 Patient Sequence Number: 1
-
-