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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMP OUT CABLE, SIMMS/LEMO CONNECTOR; ARCTIC SUN TEMP OUT CABLE
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MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMP OUT CABLE, SIMMS/LEMO CONNECTOR; ARCTIC SUN TEMP OUT CABLE Back to Search Results
Catalog Number 735-52
Device Problems Material Fragmentation (1261); Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2023
Event Type  malfunction  
Event Description
It was reported that there was no temperature measurement possible in an arctic sun device, despite cable exchange.Per follow up information received via email on 10jul2023, there was no patient involvement.Per wo updates on 07sep2023 states both of the temp out cables from the customer were broken.
 
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.
 
Event Description
It was reported that there was no temperature measurement possible in an arctic sun device, despite cable exchange.Per follow up information received via email on 10jul2023, there was no patient involvement.Per wo updates on 07sep2023 states both of the temp out cables from the customer were broken.Per follow up information received via email on 11oct2023, the device has been repaired by medtech in the hospital.Some cable were broken which are now replaced.No patient involvement.
 
Manufacturer Narrative
The reported issue was confirmed.The root cause of the reported issue is a failed temperature out cable.The device was evaluated upon receipt.The device passed calibration.It was determined that the temperature out cable was broken.Temperature cable was ordered and replaced by sales rep.It was noted that the second temperature out cable used by the customer was also broken.The device passed all testing by service technician.The serial number was unknown; therefore, the device history record could not be reviewed.Labeling review was not required since 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 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 actual/suspected device was inspected.
 
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Brand Name
ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMP OUT CABLE, SIMMS/LEMO CONNECTOR
Type of Device
ARCTIC SUN TEMP OUT 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 Key17867926
MDR Text Key325018766
Report Number1018233-2023-07164
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeAU
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 11/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number735-52
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2023
Was Device Evaluated by Manufacturer? Yes
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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