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

Device Problems Break (1069); Material Split, Cut or Torn (4008)

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 arcticsun gel pad had a cut in the thigh pad.The device was displaying alert 02 with a flow rate of 2.0l/min.Per troubleshooting, the nurse was advised that the thigh pad could be replaced with a universal.

Event Description

It was reported that the arcticsun gel pad had a cut in the thigh pad.The device was displaying alert 02 with a flow rate of 2.0l/min.Per troubleshooting, the nurse was advised that the thigh pad could be replaced with a universal.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.A potential failure mode could be '2.1 device is damaged¿ with a potential root cause of '2.1.1 improper consideration of end user requirements-shipping or handling caused damage to device.¿ the lot number is unknown; therefore, the device history record could not be reviewed.A labeling review is not required.The product code for this z300-unknown arcticgel pads product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the z300-unknown arcticgel pads product labeling is found to be adequate based on past reviews.

• Brand Name: ARCTICSUN GEL PADS
• Type of Device: ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 8976202
• MDR Text Key: 201865652
• Report Number: 1018233-2019-05462
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1