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

Catalog Number 318-02

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.A failure mode of '3.2 air leakage into the system¿ with a root cause of '3.2.1 misconnection of supply and return lines.¿ the lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "if the pad fails to prime or a significant continuous air leak is observed in the pad return line, check the connections, then if needed, replace the leaking pad.Once the pad is primes, assure the steady state flow rate displayed on the control panel is appropriate.The minimum flow rate should be 1.1 l/m".

Event Description

It was reported that the arctic sun device displayed a low air leak message.The pads were disconnected and reconnected.The flow rate increased to 3.1 lpm.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTIC SUN GEL PADS
• 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: 9126165
• MDR Text Key: 188849627
• Report Number: 1018233-2019-06007
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• 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
• Date Manufacturer Received: 09/06/2019
• 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
• Patient Sequence Number: 1