MAUDE Adverse Event Report: BARD MEDICAL / C. R. BARD, INC. ARCTIC SUN THERMAL THERAPY UNIT

Model Number 5000 E

Device Problems Break (1069); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/03/2018

Event Type  malfunction  

Event Description

A (b)(6) male (b)(6) unwitnessed cardiac arrest had arctic sun advanced thermal therapy ordered and in process.During the warming phase, the bedside nurse reported labile temperature readings, so the thermistor rectal thermometer probe was removed and replaced.The pt's temperature continued to rise slowly, 90.7-92.3 degrees f, for approx 4 hrs, followed by a rapid increase to 103.7 degrees f.The rapid increase in temperature reportedly occurred within 30 minutes.The oral temperature was taken and read 103.7, validating the issue.The arctic sun w/ rectal thermistor probe was removed and discontinued.The pt was not subject to harm related to the rapid rewarming.The hosp biomed tech reported that the interface cable from the rectal probe to the arctic sun unit was "damaged".Unfortunately, no product info for the thermistor rectal probe was reported or saved for evaluation.The arctic sun unit was sent to (b)(6) for assessment and reportedly sent to the mfr for review of the reported issue.((b)(6) = 3rd party medical device / equipment management).

• Brand Name: ARCTIC SUN THERMAL THERAPY UNIT
• Type of Device: ARCTIC SUN
• Manufacturer (Section D): BARD MEDICAL / C. R. BARD, INC.
• MDR Report Key: 7964967
• MDR Text Key: 124002801
• Report Number: MW5080547
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2018

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 Model Number: 5000 E
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 113