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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 Problem Unable to Obtain Readings (1516)
Patient Problem 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 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.
 
Event Description
It was reported that the patient's temperature was not registering on the arcticsun device.Per troubleshooting, it was explained that the issue could be caused by the temperature in cable.The biomed technician was advised that the temperature cable should be in temp port 1.
 
Manufacturer Narrative
Per additional information received, bd has determined that this mdr was initially reported in error as this event is not reportable.
 
Event Description
It was reported that the patient's temperature was not registering on the arcticsun device.Per troubleshooting, it was explained that the issue could be caused by the temperature in cable.The biomed technician was advised that the temperature cable should be in temp port 1.
 
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Brand Name
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of Device
TEMPERATURE CABLE
Manufacturer (Section D)
MEDIVANCE, INC. ¿ 1725056
321 s taylor ave
louisville CO 80027
MDR Report Key8789158
MDR Text Key151108390
Report Number1018233-2019-03903
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 07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2019
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? Yes
Date Manufacturer Received07/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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