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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
Catalog Number 5000-01-01
Device Problem Pumping Problem (3016)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/07/2021
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 per evaluation of arctin sun device, it was also found that the circulation pump was defective.This will be addressed prior to shipment.The device did not pass testing and the device was shipped to bard limited for further evaluation.Prior to bard limited repair the circulation pump was replaced, as well as the t4 sensor.The o-ring manifold was replaced due to age.After all repairs were made the arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.
 
Event Description
It was reported that per evaluation of arctin sun device, it was also found that the circulation pump was defective.This will be addressed prior to shipment.The device did not pass testing and the device was shipped to bard limited for further evaluation.Prior to bard limited repair the circulation pump was replaced, as well as the t4 sensor.The o-ring manifold was replaced due to age.After all repairs were made the arctic sun 5000 passed all performance testing, calibration, and electrical safety tests.
 
Manufacturer Narrative
Bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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.
 
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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
MDR Report Key11237698
MDR Text Key228971472
Report Number1018233-2021-00168
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 08/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number5000-01-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2020
Date Manufacturer Received08/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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