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

Catalog Number 318-02

Device Problem Insufficient Information (3190)

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

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported that the nurse stated they had a four-month-old on a neonatal pad and patient appeared to be shaking/rocking back and forth.Nurse stated it appeared the pad was causing vibrations in the patient¿s torso, and it stopped when they press down on the pad.They did not think the patient was shivering.They started cooling about an hour and a half ago.Verified patient was not shivering, seizing, or micro-shivering.Nurse unable to obtain a video or serial number for further investigation as patient was in isolation room.Advised to swap out device and call back if they continue to have issues.Per follow up information received via phone on (b)(6)2024, it was reported that therapy was completed on the baby that was 3-4 months old.They could not remember the sex of the baby.Changed the gel pads multiple times but realized if they applied pressure to the pads, the vibration stopped.The device did not go to bomed.

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.H3 other text : the device was not returned.

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 the nurse stated they had a four-month-old on a neonatal pad and patient appeared to be shaking/rocking back and forth.Nurse stated it appeared the pad was causing vibrations in the patient¿s torso, and it stopped when they press down on the pad.They did not think the patient was shivering.They started cooling about an hour and a half ago.Verified patient was not shivering, seizing, or micro-shivering.Nurse unable to obtain a video or serial number for further investigation as patient was in isolation room.Advised to swap out device and call back if they continue to have issues.Per follow up information received via phone on 23apr2024, it was reported that therapy was completed on the baby that was 3-4 months old.They could not remember the sex of the baby.Changed the gel pads multiple times but realized if they applied pressure to the pads, the vibration stopped.The device did not go to bomed.

• 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: 19180179
• MDR Text Key: 341618147
• Report Number: 1018233-2024-02282
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741132131
• UDI-Public: (01)00801741132131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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: 318-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 4 MO