MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000 ARCTIC SUN DEVICE

Model Number 50000000E

Device Problems Insufficient Cooling (1130); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2021

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 (b)(6) device was rewarmed rapidly and was set to warm 0. 25c/hr but rewarmed from 36c to 37. 1c in 1. 5 hrs and now up to 38. 9c. Also stated it should be 37c. Water temperature was 29c. The (b)(6) device got an alert 113 (reduced water temperature control) last night and the caller explained that the nurse had fixed it by emptying the pads. An alert 113 (reduced water temperature control) has been alerting for a few hours before the user called. The device was placed in manual mode but still the water temperature was not dropped. The user would notify the managing director that rewarm happened rapidly and would call supervisors to help locating another device. Per additional information received on 06apr2021, received data files. It was verified that they had connected the fill tube across the drain ports which resulted in the device not being able to cool.

• Brand Name: ARCTIC SUN® 5000
• Type of Device: ARCTIC SUN DEVICE
• 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: 11727155
• MDR Text Key: 247470830
• Report Number: 1018233-2021-02389
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 04/26/2021 Patient Sequence Number: 1