MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICSUN GEL PADS ARCTIC SUN GEL PAD

Catalog Number 317-00

Device Problems Use of Device Problem (1670); Gas Leak (2946); Infusion or Flow Problem (2964)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.

Event Description

It was reported that there was a low air leak and low flow on the arctic sun device. The patient temperature was 38c with a target temperature of 36. 5c. The flow rate was 1. 1l/min, and the water temperature was 5. 6c but the nurse stated the pads did not feel cold on the patient. Per troubleshooting with ms&s, the nurse stated that the patient only had two universal pads on because the unit did not have a full set of pads available. The nurse was advised to locate a full set of pads to properly deliver therapy. The nurse stated she would check in another unit or neighboring hospitals for a full set of pads. Per follow up with nurse (b)(6) via phone on 22jul2019, the patient was continuing therapy successfully with no further issues with a new set of pads.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTIC SUN GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 321 s taylor ave; louisville, CO 80027 ; 7707846100
• MDR Report Key: 8884259
• MDR Text Key: 184694547
• Report Number: 1018233-2019-04654
• Device Sequence Number: 1
• Product Code: DWJ
• 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: health professional,other,use

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 317-00
• 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: 08/28/2019
• 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