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U.S. Department of Health and Human Services

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

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN DEVICE Back to Search Results
Catalog Number 5000-01-01
Device Problems Defective Component (2292); Naturally Worn (2988); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
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 as per evaluation of arctic sun device, the circulation pump was very noisy and found to be on it¿s wear limit.
 
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Brand NameARCTIC SUN DEVICE
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key10384438
MDR Text Key203340495
Report Number1018233-2020-05088
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5000-01-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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