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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 Device Inoperable (1663); Defective Component (2292)
Patient Problems No Patient Involvement (2645); 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. 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.
 
Event Description
It was reported that during completion of the service record investigation for this device, a faulty mixing pump was found.
 
Manufacturer Narrative
The reported issue of the unit not cooling was confirmed with a functional capacity test. The root cause was isolated to a mixing pump issue; as the circulation pump controls filling/flow. Flow was fine. The tech stated once the parts (pumps) were replaced the unit was retested and cooled to set temperatures. Pump will be replaced during preventative maintenance (pm). Pm was performed. Per the pm procedure; pumps, heater and drain ports were replaced. The device was cleaned and an electrical safety test was performed and passed. The device history record was reviewed and found nothing that could have caused or contributed to the reported event. 1018233-2018-01882-1.
 
Event Description
It was reported that during completion of the service record investigation for this device, a faulty mixing pump was found.
 
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Brand NameARCTIC SUN 5000
Type of DeviceARCTIC SUN DEVICE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key7542189
MDR Text Key109383311
Report Number1018233-2018-01882
Device Sequence Number1
Product Code DWJ
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 06/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2018
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 Manufacturer10/18/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

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