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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 Problems Circuit Failure (1089); Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2021
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 had an alarm 81 and also needs to come for the 2000 hour pm service.Per evaluation, the neutral connection between the power inlet module and the ac main voltage circuit card showed signs of electrical over stress.These both would need to be replaced.There was a pixelated green line in the display extending 2 inches from the right bottom.It did not appear to affect the touchscreen functions under it.There was an indicator that the control panel was starting to fail.It was recommended to be replaced as a preventive measure.The processor circuit card was found slightly askew in the card cage indicating that it was not seated correctly in the back panel of the cage.The processor circuit card was re-seated during the assessment.
 
Manufacturer Narrative
The reported issue was confirmed by capa association as manufacturing related.The root cause of the reported issue was covered in capa #1405844.The neutral connection between the power inlet module and the ac main voltage circuit card shows signs of electrical overstress.The power inlet module and the ac main voltage circuit card was replaced and a shock sensor was applied to the lower bracket and loctite to all casters.All upgrades were verified complete in accordance with service procedures.The arctic sun 5000 passed all performance testing, calibration and electrical safety tests and is functioning properly and ready for use.The overheating of the wires was assessed by the investigation tasks and used to complete the root cause evaluation using the fishbone methodology (refer to ac cca power inlet module powerpoint for fishbone diagram).It was concluded that the following was the root cause: supplier ¿ root cause 1.Inadequate verification and validation activities of the crimping process 2.Single pull test did not provide stability of process 3.Evidence was not provided when requested for maintenance of records or crimp tools 4.No crimp cross-sections provided.The device history record review was not required as the complaint was addressed by existing capa.Labeling review was not required as the complaint was addressed by existing capa.The actual/suspected device was inspected.
 
Event Description
It was reported that the arctic sun device had an alarm 81 and also needs to come for the 2000 hour pm service.Per evaluation, the neutral connection between the power inlet module and the ac main voltage circuit card showed signs of electrical over stress.These both would need to be replaced.There was a pixelated green line in the display extending 2 inches from the right bottom.It did not appear to affect the touchscreen functions under it.There was an indicator that the control panel was starting to fail.It was recommended to be replaced as a preventive measure.The processor circuit card was found slightly askew in the card cage indicating that it was not seated correctly in the back panel of the cage.The processor circuit card was re-seated during the assessment.
 
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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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key11563624
MDR Text Key242643544
Report Number1018233-2021-01567
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 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
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? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2014
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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