MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS UNKNOWN ARCTIC GEL PADS

Device Problems Insufficient Flow or Under Infusion (2182); Misassembly by Users (3133)

Patient Problems Shaking/Tremors (2515); Alteration In Body Temperature (2682); Patient Problem/Medical Problem (2688)

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 was getting low flow and getting an alarm that the water temperature too low for too long. Therapy had been started at 05:30, the patient temperature was 34. 6c, the target temperature was 33c, the water temperature was 5c, the flow rate was 1. 5 l/m. The patient was about 400 lbs. Patient was shivering and having myoclonic jerks. There were 5 arctic gel pads in use and trend with one arrow down. The temperature was reading via esophageal and foley probe and correlating. The patient was on propofol and was getting tylenol and buspar. Disconnected and reconnected arctic gel pads were using proper technique. The flow rate was 1. 8-2. 1 l/m. Recommended checking skin under arctic gel pads to assess for skin injury and ensuring that the arctic gel pads were not bunching up under the patient. Advised that myoclonic jerks and shivering was a cause of patient not achieving target temperature.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTIC GEL PADS
• 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: 10607045
• MDR Text Key: 209187915
• Report Number: 1018233-2020-06256
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 09/30/2020 Patient Sequence Number: 1