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

Model Number 50000000E

Device Problems Use of Device Problem (1670); Operating System Becomes Nonfunctional (2996)

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

Event Date 09/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the patient was on arctic sun device, therapy was running fine until they took the patient to ct scan.When they returned, they cannot get the touchscreen to respond to their touch.They had powered it off and back on a few times, but they cannot push start.Mss asked nurse to send the device to biomed and the device should be inspected.Mss advised the nurse to change another arctic sun device.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue was inadequate maintenance of screen.The patient was on arctic sun device, therapy was running fine until they took the patient to ct scan.When they returned, they cannot get the touchscreen to respond to their touch.The device did not meet specifications, and was influenced by the reported failure.The device was in use on a patient.The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "cleaning and maintenance routine cleaning and preventative maintenance should be performed on the arctic sun temperature management system control module every 6 months at a minimum.This consists of cleaning the external surfaces, accessories and chiller condenser, inspecting the device, and replenishing the internal cleaning solution that suppresses microorganism growth in the water reservoir and hydraulic circuit.External surfaces clean the exterior body of the control module, fluid delivery lines, power cords and temperature cables using a soft cloth and mild deter- gent or disinfectant according to hospital protocol." h11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.H3 other text : the device was not returned.

Event Description

It was reported that the patient was on arctic sun device, therapy was running fine until they took the patient to ct scan.When they returned, they cannot get the touchscreen to respond to their touch.They had powered it off and back on a few times, but they cannot push start.Mss asked nurse to send the device to biomed and the device should be inspected.Mss advised the nurse to change another arctic sun device.Per follow up information received on 15sep2021, updated device was sent to biomed.Unknown what device was used to continue therapy.Per follow up information received on 16sep2021, updated junk was all over the screen.He cleaned the screen then calibrated it and put device back in service.

• 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: 12569384
• MDR Text Key: 274529686
• Report Number: 1018233-2021-06164
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other