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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM; TEMPERATURE CABLE
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM; TEMPERATURE CABLE Back to Search Results
Catalog Number 735-02
Device Problems Display or Visual Feedback Problem (1184); Device Sensing Problem (2917)
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.
 
Event Description
It was reported that there were sensing issues with the arcticsun temperature cable.The patient was 31c, the water was 41c, and the flow rate was 2.4l/min.The device displayed multiple alert 11, 14, and 51.Per troubleshooting, the biomed was advised to switch out the cable.
 
Manufacturer Narrative
The reported issue was inconclusive.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be a defective temperature cable.However, this cannot be confirmed.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "temperature probe placement patient temperature control with the arctic sun® temperature management system requires patient temperature feedback provided by an indwelling patient temperature probe connected to the patient temperature 1 connector on the back of the control module.Any commercially-available yellow springs instrument 400 series (ysi 400) compatible patient temperature probe can be connected to the arctic sun® temperature management system.Refer to the manufacturer¿s instructions for use ¿ medivance recommends measuring patient temperature from a second site to verify patient temperature.Medivance recommends the use of a second patient temperature probe connected to the arctic sun® temperature management system temperature 2 input as it provides continuous monitoring and safety alarm features.Alternatively, patient temperature may be verified periodically with independent instrumentation.¿ the displayed temperature graph is for general information purposes only and is not intended to replace standard medical record documentation for use in therapy decisions.¿ patient temperature will not be controlled and alarms are not enabled in stop mode.Patient temperature may increase or decrease with the arctic sun® temperature management system in stop mode." correction: d10, h5 h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.
 
Event Description
It was reported that there were sensing issues with the arcticsun temperature cable.The patient was 31c, the water was 41c, and the flow rate was 2.4l/min.The device displayed multiple alert 11, 14, and 51.Per troubleshooting, the biomed was advised to switch out the cable.
 
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Brand Name
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM
Type of Device
TEMPERATURE CABLE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key9812907
MDR Text Key185300311
Report Number1018233-2020-01705
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 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number735-02
Was Device Available for Evaluation? No
Date Manufacturer Received04/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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