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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARCTIC GEL PADS
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MEDIVANCE, INC. ¿ 1725056 UNKNOWN ARCTICGEL PADS; ARCTIC GEL PADS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/30/2023
Event Type  malfunction  
Event Description
It was reported that nurse stated they were getting an alert 113 (reduced water temperature was control) on an arctic sun device.The patient was almost at target, but water temperature seemed to stuck around 30c.Patient temperature was 36c, targeted temperature was 35.7c, water temperature was 30.5c and flow rate was 2.5lpm.Guided to system hours were 10694, pump hours were 10258, heater command was 0 percentage, mixing pump command was 100 percentage and chiller temperature was 4.4c.Advised they send that to biomed and tag it for possible mixing pump failure.They stated they already changed pads and device prior to calling but was getting errors with the other device as well.They would try it and call back if needed.No further calls from that customer.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 nurse stated they were getting an alert 113 (reduced water temperature was control) on an arctic sun device.The patient was almost at target, but water temperature seemed to stuck around 30c.Patient temperature was 36c, targeted temperature was 35.7c, water temperature was 30.5c and flow rate was 2.5lpm.Guided to system hours were 10694, pump hours were 10258, heater command was 0 percentage, mixing pump command was 100 percentage and chiller temperature was 4.4c.Advised they send that to biomed and tag it for possible mixing pump failure.They stated they already changed pads and device prior to calling but was getting errors with the other device as well.They would try it and call back if needed.No further calls from that customer.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause was not chosen due to a lack of information.The device history record review could not be performed without a lot number.A labeling review was not completed due to a lack of information.H11: section a through f - the information provided by bd represents all 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.
 
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Brand Name
UNKNOWN ARCTICGEL PADS
Type of Device
ARCTIC GEL PADS
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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18365248
MDR Text Key331060427
Report Number1018233-2023-09084
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142702
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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