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

Device Problem Use of Device Problem (1670)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2020

Event Type  malfunction  

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 received a low flow alert (alert 02) and the flow rate was 1. 0 lpm. While checking for the kinks in the lines and emptying the arctic gel pads, the nurse stated that there were two arctic gel pads on the thighs. Ms&s explained that this was not sufficient for cooling and not sufficient for maintaining the target temperature. Also, stated that the low flow had nothing to do with the amount of water in the arctic sun device and showed where the water level indicator was located and asked how to fill the arctic sun device. They were targeted for normothermia of 37. 0c and the patient temperature was 37. 2c, but the nurse stated the temperature had gone up to the 39c range. Ms&s advised that they should get a low reservoir alarm to call back the helpline. The nurse asked whether they could trick the arctic sun device by adding the pads, but not placed them on the patient. Ms&s explained that this could be done, but the arctic sun device would not be efficient in maintaining the target temperature. The patient had some sort of ostomy.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ARCTICGEL 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 Key: 11123333
• MDR Text Key: 225291675
• Report Number: 1018233-2020-22307
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: No
• 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: 03/31/2021
• 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: 01/06/2021 Patient Sequence Number: 1