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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; ARCTIC SUN TEMPERATURE CABLE
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE; ARCTIC SUN TEMPERATURE CABLE Back to Search Results
Device Problems Failure to Sense (1559); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2023
Event Type  malfunction  
Event Description
It was reported that the arctic sun device had faulty temperature probe.Sales representative had sent the customer a new temperature cable.Per follow up information received via email on 27nov2023, issue was resolved on site by changing the temperature in cable.Change of temperature in cable was done to repair.Patient swapped onto a different arctic sun and no impact to the patient.Problem was with the cable.
 
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 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 arctic sun device had faulty temperature probe.Sales representative had sent the customer a new temperature cable.Per follow up information received via email on 27nov2023, issue was resolved on site by changing the temperature in cable.Change of temperature in cable was done to repair.Patient swapped onto a different arctic sun and no impact to the patient.Problem was with the cable.
 
Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is a failed temperature in cable.Sales representative had sent the customer a new temperature cable.Per follow up information, issue was resolved on site by changing the temperature in cable.Change of temperature in cable was done to repair.Patient swapped onto a different arctic sun and no impact to the patient.Problem was with the cable.The serial number is unknown; therefore, the device history record could not be reviewed.The labelling review is not required as the complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.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.
 
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Brand Name
ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE
Type of Device
ARCTIC SUN TEMPERATURE CABLE
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 Key18265643
MDR Text Key329718172
Report Number1018233-2023-08720
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K161602
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 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 11/16/2023
Initial Date FDA Received12/05/2023
Supplement Dates Manufacturer Received03/30/2024
Supplement Dates FDA Received04/01/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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