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

Model Number 60000000

Device Problems Restricted Flow rate (1248); Use of Device Problem (1670)

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

Event Date 10/05/2022

Event Type  malfunction  

Event Description

It was reported that the biomed had an arctic sun device brought down from the floor because it was alerting that water was needed.Nurse had drained the device and was trying to fill, but device was not sucking up water.Mss verified placement of fill tube, added cleaning solution and no pads were attached.When select fill reservoir they could hear the device power, but nothing occurs.Biomed was unsure when the last time the device was calibrated.Mss recommended they could run a calibration to see if they receive any error messages.If device was not sucking up the water, then there could be a pump issue.

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 biomed had an arctic sun device brought down from the floor because it was alerting that water was needed.Nurse had drained the device and was trying to fill, but device was not sucking up water.Mss verified placement of fill tube, added cleaning solution and no pads were attached.When select fill reservoir they could hear the device power, but nothing occurs.Biomed was unsure when the last time the device was calibrated.Mss recommended they could run a calibration to see if they receive any error messages.If device was not sucking up the water, then there could be a pump issue.Per follow up information received via phone on 26oct2022, the device was working fine, biomed stated that nurse was using incorrect tube.

Manufacturer Narrative

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

• Brand Name: ARCTIC SUN STAT
• 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: 15620078
• MDR Text Key: 302496597
• Report Number: 1018233-2022-07899
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60000000
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2023
• 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