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

Model Number 50000000E

Device Problems Insufficient Heating (1287); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Paralysis (1997); Alteration In Body Temperature (2682)

Event Type  malfunction  

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 baby was not heating on the arctic sun device. Last night pad was soiled so they changed it. Since then they got an alert 02 on the device and the baby was below target temperature (37c). Ms&s asked what the flow number were and the nurse stated 1. 1-1. 5lpm. Ms&s told that the flow was acceptable for neonate pads. Complainant documented that patient temperature twice as 33c and the water was 29c for the first and as 36c and the water was 34c for the second. Ms&s had the nurse check the graph and the patient temperature with another source. The nurse stated the baby was paralyzed, with no warmers on, or infections. Then nurse stated there was surface counter-warmers on and that the vent circuit was set to 37c. Ms&s asked to turn off the counter-warmers. The nurse could not turn down the vent circuit. Ms&s asked to call in an hour if still concern for patient not being at goal. Per follow up, the biomed could not locate the device.

• Brand Name: ARCTIC SUN 5000
• Type of Device: ARCTICSUN 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: 10095968
• MDR Text Key: 193297321
• Report Number: 1018233-2020-03485
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

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: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse