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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 50000000E
Device Problem Pressure Problem (3012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 in biomed for the 6 month pm and during the fluid delivery line test it was observed that the inlet pressure would not get to -7.0 on any of the fluid delivery line valves.
 
Manufacturer Narrative
Per additional information received, bd has determined that this is not a reportable event.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.
 
Event Description
It was reported that the arctic sun device was in biomed for the 6 month pm and during the fluid delivery line test it was observed that the inlet pressure would not get to -7.0 on any of the fluid delivery line valves.
 
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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
louisville CO 80027
MDR Report Key10479550
MDR Text Key206302677
Report Number1018233-2020-05610
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741127755
UDI-Public(01)00801741127755
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 01/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number50000000E
Device Catalogue Number50000000E
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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