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

Device Problems Device Sensing Problem (2917); Protective Measures Problem (3015)

Patient Problems No Consequences Or Impact To Patient (2199); 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 device was not returned.

Event Description

It was reported that the arctic sun device was beeping while in use on a patient.The nurse stated the event log was showing an alert 50 (patient temperature erratic) and alarm 15 (unable to obtain stable patient temperature).Per troubleshooting, (b)(4)advised the nurse in the room to swap the cable to see if it corrected the issue.The nurse stated she would ask the charge nurse for another cable.

Event Description

It was reported that the arctic sun device was beeping while in use on a patient.The nurse stated the event log was showing an alert 50 (patient temperature erratic) and alarm 15 (unable to obtain stable patient temperature).Per troubleshooting, ms&s advised the nurse in the room to swap the cable to see if it corrected the issue.The nurse stated she would ask the charge nurse for another cable.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿temperature probe placement patient temperature control with the arctic sun® temperature management system requires patient temperature feedback provided by an indwelling patient temperature probe connected to the patient temperature 1 connector on the back of the control module.Any commercially-available yellow springs instrument 400 series (ysi 400) compatible patient temperature probe can be connected to the arctic sun® temperature management system.Refer to the manufacturer¿s instructions for use for the specific indications and temperature probe placement." 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.

• 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; louisville CO 80027
• MDR Report Key: 9233339
• MDR Text Key: 177216710
• Report Number: 1018233-2019-06747
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/24/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1