MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PADS

Catalog Number 317-05

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that during patient's use, there was a strange noise from the connection and a low-flow alarm sounded.Air contamination was suspected and the problem was corrected when the gel pad was replaced.It was noted that there was no patient injury was reported.Per investigator notification received via mail on (b)(6) 2024, it was reported that there was a chipped connector , separated hydrogel , kinked lines and cut tubing jacket found in the sample analysis.

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTIC GEL PADS
• 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: 19031311
• MDR Text Key: 339224200
• Report Number: 1018233-2024-01800
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741080067
• UDI-Public: (01)00801741080067
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 317-05
• Device Lot Number: NGHN0897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other