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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 50000101
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2021
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 during the preliminary functional test, a metallic rattling noise was heard from the device.It was localized in the hgbv, the preventive maintenance.When the water was emptied, it was determined that it was very heavily contaminated, it had a brown color and dirt particles.
 
Manufacturer Narrative
The reported issue was unconfirmed.The root cause of the reported issue was unable to be determined, as the device met specifications during evaluation.The technician cannot confirm contamination in the device.The unit underwent preventive maintenance (pm) servicing as normal.Device passed all final test procedures after replacement of preventive maintenance components.The device history record review and labeling review was not required as the reported event was unconfirmed.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 actual/suspected device was inspected.
 
Event Description
It was reported that during the preliminary functional test, a metallic rattling noise was heard from the device.It was localized in the hgbv, the preventive maintenance.When the water was emptied, it was determined that it was very heavily contaminated, it had a brown color and dirt particles.
 
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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 Key11905870
MDR Text Key253545688
Report Number1018233-2021-03124
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeGM
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/07/2021
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 Catalogue Number50000101
Device Lot Number5410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/06/2021
Initial Date FDA Received05/30/2021
Supplement Dates Manufacturer Received12/07/2021
Supplement Dates FDA Received12/13/2021
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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