MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTICGEL PADS

Catalog Number 317-05-02

Device Problems Loss of or Failure to Bond (1068); Therapeutic or Diagnostic Output Failure (3023)

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.

Event Description

It was reported that the arctic sun device displayed a low flow alert. The flow rate was 0. 7lpm. With the pads attached and device running, the fr
=
0. 7l/min, ip -7psi and cp
=
27%. There were no bends or kinks in the tubing. While checking the pads, the nurse noted that they were not sticking to the patient's torso and the hydrogel was not sticky. Ms&s explained that lotion or oil on the patient's skin could prevent adherence. The nurse changed the pads.

• Brand Name: ARCTICGEL PADS
• Type of Device: 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: 9825798
• MDR Text Key: 186182598
• Report Number: 1018233-2020-01792
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/30/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 317-05-02
• Device Lot Number: NGDR0530
• 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: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial