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

Device Problems Component Missing (2306); Device Displays Incorrect Message (2591); Connection Problem (2900); Device Sensing Problem (2917)

Patient Problems No Patient Involvement (2645); 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 nurse was trying to start therapy on the arctic sun device but was getting an alarm 16.She stated she had already changed the esophageal probe once and was unable to connect to the beside monitor, as it did not have the right type of connection.All their other machines were in use at the time.Per follow up with nurse (b)(6) via phone on (b)(6) 2019, they were unable to get another cable.The biomed attempted to fix the cable they had in the device, but the issue was not resolved.They were unable to start therapy on the patient, and the device was sent to biomed.Per additional information received via phone on 25sep2019, a biomed technician stated that the cable was functioning properly in the biomed department.

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.They had already changed the esophageal probe once and were unable to connect to the beside monitor, as it did not have the right type of connection.Per follow up, they were unable to get another cable.The biomed attempted to fix the cable they had in the device, but the issue was not resolved.They were unable to start therapy on the patient, and the device was sent to biomed.Per additional information, a biomed stated that the cable was functioning properly in the biomed department.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: "periodically inspect the external areas of the device for damaged, loose or missing parts, and frayed or twisted power cords and cables.Discontinue using the device displaying one or more of the above conditions until the problem is corrected and has been verified to be operating correctly." 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 evaluated by the facility's biomed.

Event Description

It was reported that the nurse was trying to start therapy on the arctic sun device but was getting an alarm 16.She stated she had already changed the esophageal probe once and was unable to connect to the beside monitor, as it did not have the right type of connection.All their other machines were in use at the time.Per follow up with nurse joanne via phone on (b)(6)2019, they were unable to get another cable.The biomed attempted to fix the cable they had in the device, but the issue was not resolved.They were unable to start therapy on the patient, and the device was sent to biomed.Per additional information received via phone on (b)(6)2019, a biomed technician stated that the cable was functioning properly in the biomed department.

• 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: 9194290
• MDR Text Key: 179750961
• Report Number: 1018233-2019-06505
• 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: 10/21/2019

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
• Event Location: Home
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 10/17/2019
• Supplement Dates FDA Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1