MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS ARCTIC GEL PAD NEONATAL

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. ".

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL PADS
• Type of Device: ARCTIC 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 Key: 10091597
• MDR Text Key: 192179636
• Report Number: 1018233-2020-03360
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• 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 Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 318-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/30/2020
• 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