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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 5000; ARCTIC SUN DEVICE Back to Search Results
Model Number 50000000
Device Problem No Display/Image (1183)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2022
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 arctic sun device was on, but the screen was blank.Mis advised that they need to swap out to a different device and send to biomed for repair.As per follow-up information, received via email on 15dec2022, biomed told nurse that it repeated booted to an alarm 47 (control panel communication).They discussed that they would need to investigate further to isolate the problem to the control panel, wiring, or the processor card.Biomed stated that they would replace the part once they determined the root cause.
 
Manufacturer Narrative
Upon further review, bd has determined that this event is not reportable.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 arctic sun device was on, but the screen was blank.Mis advised that they need to swap out to a different device and send to biomed for repair.As per follow up information received via email on 15dec2022, biomed told nurse that it repeated booted to an alarm 47 (control panel communication).They discussed that they would need to investigate further to isolate the problem to the control panel, wiring, or the processor card.Biomed stated that they would replace the part once they determined the root cause.Per follow up information received via phone on 29dec2022, biomed stating that they had replaced the control panel, but they tried to fill the device and device was leaking out of the front per email response received from technician support and biomed communication on 30dec2022, biomed did not add the cleaning solution when refilling, so they overfilled the tank.Per review of wo on 01jan2023, there was no patient involvement.
 
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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 Key16067959
MDR Text Key307726409
Report Number1018233-2022-09977
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741080142
UDI-Public(01)00801741080142
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
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 05/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2022
Initial Date FDA Received12/29/2022
Supplement Dates Manufacturer Received05/11/2023
Supplement Dates FDA Received05/12/2023
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 Number1
Patient Outcome(s) Other;
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