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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 50000000
Device Problems Defective Component (2292); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); 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 the biomed received the device with a note stating that the device did not read temperature correctly and did not heat the patient. The event log was reviewed, and only an alert 45 (ac power lost) was noted. Per biomed, data could not be retrieved because the flash drives were encrypted when connected to their computers. The device was placed in manual mode and target was set to 4c. The device was put in bypass mode, the flow rate was 1. 7 l/min, inlet pressure was -7. 1 psi, circulation pump was 53%, t1 was 5. 8c, and t4 was 3. 6c. The target was changed to 42c, however the water did not increase above 14c after 10-15 minutes. The complainant was transferred to ess to discuss the preventative maintenance program.
 
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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
Manufacturer (Section G)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7355092
MDR Text Key103188819
Report Number1018233-2018-00883
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K161602
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number50000000
Device Catalogue Number50000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2015
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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