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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 Problems Failure to Pump (1502); Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
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 when the arctic sun device powered on the screen did not light up stayed black and there was no view. Per investigation of the device with serial number (b)(4) completed on (b)(6) 2021 it was stated that after the screen replacement the new panel came to make strange noises and high beep tones. A new panel was needed to get reassembled and swapped with another new one. It was noted that when the other new panel came in it was found to have a cracked bezel and was shipped back for repair. Per sample evaluation both the pumps were on wear limit.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC 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 Key12358855
MDR Text Key267840024
Report Number1018233-2021-05117
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)Y
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
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 Manufacturer11/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 08/24/2021 Patient Sequence Number: 1
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