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

Model Number 50000000

Device Problems Inaccurate Flow Rate (1249); Defective Component (2292)

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

Event Date 11/04/2022

Event Type  malfunction  

Event Description

It was reported that the biomed stated they were having trouble filling their arctic sun device.The floor initially received a low flow alert and sent it to biomed.Biomed stated when they powered it on, it gave an empty reservoir alert.Biomed emptied the reservoir and got out 1 liter of water.When tried to fill it back up, it pulled in a little water and stopped and would not completely fill.Per additional information received on (b)(6) 2022, after confirming the biomed was using the correct water mixture, it was determined that the device needed a new level sensor.Biomed would order and replace onsite.

Manufacturer Narrative

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

Manufacturer Narrative

Upon further review of investigation, bd has determined that this mdr is not reportable.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text: the device was not returned.

Event Description

It was reported that the biomed stated they were having trouble filling their arctic sun device.The floor initially received a low flow alert and sent it to biomed.Biomed stated when they powered it on, it gave an empty reservoir alert.Biomed emptied the reservoir and got out 1 liter of water.When tried to fill it back up, it pulled in a little water and stopped and would not completely fill.Per additional information received on 14nov2022, after confirming the biomed was using the correct water mixture, it was determined that the device needed a new level sensor.Biomed would order and replace onsite.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15843926
• MDR Text Key: 307618700
• Report Number: 1018233-2022-08889
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080142
• UDI-Public: (01)00801741080142
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 50000000
• Device Catalogue Number: 50000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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