MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE BARD; TEMP CABLE BARD

Model Number	73503
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that when the cable was connected to the arctic sun 5000 and tried to use on the patient, the patient temperature was not displayed.When replaced the bladder temperature sensor and the cable with another one, it was confirmed that there was a problem with the product.
Additional Manufacturer Narrative
The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.The device was evaluated upon receipt.The temperature cable was connected to pt1 of a test as5000 on one end and a test temperature simulator key on the other end.The test temperatures of 33, 37, and 39 degrees c were displayed in sequence on the as5000 pt1 section of the screen.The cable was put through a stress test to detect any opens or shorts in the cable or cable ends by means of twisting, bending, and stretching the cable while connected to the as5000.No opens or shorts were detected during all the stress tests applied.Simulated temperatures read consistent on the as5000 screen.Component scrapped.The reported event is unconfirmed, labeling/packaging review is not required.The reported event is unconfirmed, dhr review is not required.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.
Event or Problem Description
It was reported that when the cable was connected to the arctic sun 5000 and tried to use on the patient, the patient temperature was not displayed.When replaced the bladder temperature sensor and the cable with another one, it was confirmed that there was a problem with the product.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE BARD
• Common Device Name: TEMP CABLE BARD
• 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 Key: 16295042
• Report Number: 1018233-2023-00599
• Device Sequence Number: 6082899
• Product Code: DWJ
• UDI-Device Identifier: 00801741080302
• UDI-Public: (01)00801741080302
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 73503
• Device Catalogue Number: 73503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown