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

Catalog Number 735-02

Device Problems Display or Visual Feedback Problem (1184); Fracture (1260); Naturally Worn (2988)

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.

Event Description

It was reported that an arctic sun device displayed an alert 50 and alarm 15.The biomed checked the cable and it was frayed.

Manufacturer Narrative

The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be a defective temperature cable.However, this cannot be confirmed.The biomed checked the cable and it was frayed.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.

Event Description

It was reported that an arctic sun device displayed an alert 50 and alarm 15.The biomed checked the cable and it was frayed.

• Brand Name: ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, TEMPERATURE CABLE NELLCOR
• Type of Device: TEMP IN CABLE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9841621
• MDR Text Key: 186020944
• Report Number: 1018233-2020-01851
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

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
• Device Catalogue Number: 735-02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2020
• Initial Date FDA Received: 03/17/2020
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1