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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 6000 ARCTIC SUN DEVICE

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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® 6000 ARCTIC SUN DEVICE Back to Search Results
Model Number 60000000
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/05/2022
Event Type  malfunction  
Event Description
It was reported that the arctic sun device was failing calibration for an error 05 (inlet pressure out of range). A check of the inlet pressure reading with the inlet open to atmosphere showed the inlet pressure still read -1. 3psi. Mss stated that this was indicative of a failed pressure transducer. The device would be brought back for warranty repair. Per sample evaluation results received on (b)(6) 2022, it was noted that the front chiller caster mount plate had broken free from the chiller frame. It was also noted that the usb cover was missing. It was stated that minor cosmetic scratches were noted on the handle device when the device was visually inspected. It was also stated that they did not affect the operation of the device.
 
Manufacturer Narrative
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed.
 
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Brand NameARCTIC SUN® 6000
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
juan velez
8195 industrial blvd
covington 30014
7707846100
MDR Report Key15083860
MDR Text Key303641826
Report Number1018233-2022-05679
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier00801741161513
UDI-Public(01)00801741161513
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 07/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number60000000
Device Catalogue Number60000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/05/2022
Was Device Evaluated by Manufacturer? No
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: 07/22/2022 Patient Sequence Number: 1
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