MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN 5000 ARCITCSUN DEVICE

Model Number 50000000E

Device Problems Device Alarm System (1012); Device Sensing Problem (2917); Temperature Problem (3022)

Patient Problems Seizures (2063); Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 the patient was below the target temperature while on the arcticsun device. The patient was set to rewarm from 36. 5c, and the device was alarming 115 (prolonged warm water exposure). The water temperature was 39c, the flow rate was 1. 1l/min, the baby was in a 'nest', the radiant heat was 10%, and the trend was pointing down. The nurse was advised to increase the radiant heat. The nurse was called back an hour later and stated that the radiant heat was increased and the patient reached the 36. 5 target temperature. Additional information was received on 09dec2019 from the nurse who stated the baby was seizing while on the device, and phenobarbital and keppra was administered. Once they increased the radiant heater, the patient was able to reach target and complete therapy.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCITCSUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9497982
• MDR Text Key: 178589781
• Report Number: 1018233-2019-08121
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 50000000E
• Device Catalogue Number: 50000000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/19/2019 Patient Sequence Number: 1