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

Model Number 50000000E

Device Problem Computer Operating System Problem (2898)

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

Event Date 10/19/2020

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 as per additional information received via mss data (salesforce (b)(4)) from (b)(6) 2020 on (b)(6) 2020, there was a device sensing issue.Nurse stated screen was frozen.Ms&s tried to have her go into room to calibrate, but it was a covid patient and she was unable to do so.Ms&s explained how to calibrate the screen, but she was unable to get any of the buttons to work even after turning device off/on.Ms&s had her try to tap around the buttons but screen was still not responding.She stated she would send device to biomed.(b)(6) called to state that the control panel screens were not accessible.The touch points had been rotated 180 degrees.He stated he was able to perform a calibration, but upon reboot, the calibration data had clearly not been retained.The device is under warranty so a replacement panel will be sent at no charge.Replacement part order # (b)(4).

Manufacturer Narrative

The reported issue was confirmed by capa association as manufacturing related.The root cause was being investigated under capa.It was found that the control panel screen unresponsive to touch and unable to download patient data due to frozen screen.The control panel was replaced.Unit was returned without power cord bracket.The unit and components were inspected, and the condenser coil was cleaned.A power cord bracket was added to the unit.Verified all upgrades were complete.Run system functional checks after repairs.The repairs corrected the reported issues, and the unit was functioning properly.The arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.The unit is ready for use.The device history record review and labeling review was not performed as the complaint was addressed by existing capa.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 actual/suspected device was inspected.

Event Description

It was reported that there was a device sensing issue in the arctic sun device.Nurse stated screen was frozen.Mss tried to have nurse into room to calibrate, but it was a covid patient and the nurse was unable to do so.Mss explained how to calibrate the screen, but the nurse was unable to get any of the buttons to work even after turning device off/on.Mss had nurse try to tap around the buttons but screen was still not responding.Nurse stated the device would send to biomed.Biomed called to state that the control panel screens were not accessible.The touch points had been rotated 180 degrees.Biomed was able to perform a calibration, but upon reboot, the calibration data had clearly not been retained.Per sample evaluation, the unit was returned without power cord bracket and a power cord bracket was added to the unit.

• 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
• MDR Report Key: 10823272
• MDR Text Key: 222819029
• Report Number: 1018233-2020-20857
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741127755
• UDI-Public: (01)00801741127755
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other