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

Catalog Number 317-03

Device Problems Inaccurate Flow Rate (1249); Connection Problem (2900)

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 information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the device received an alarm 01 and 02.The complainant checked the connection between the gel pad and the fluid delivery line and tried to reconnect but there was no improvement.

Manufacturer Narrative

The reported issue (it was reported that the device received an alarm 01 and 02.The complainant checked the connection between the gel pad and the fdl and tried to reconnect but there was no improvement) was confirmed.Visual inspection noted the tubing insulation was torn off and stuck to one of the pads upon return.The right chest pad was found to have the energy connector damaged (curved in), the left chest, left thigh, and right thigh pads were found to have the energy connectors free of damage, and all the pads were found to have the trim pattern correctly performed.The plastic tubes were found completely assembled covering the total of clamping rings on the manifold connector.The seal between the manifold connector and pad was found completed sealed and the pads were noted with sealing presence.No manufacturing issues related were noted during the visual evaluation of the pads returned.The flow rate was found to be unacceptable for the right chest pad (the flow rate was inconsistent due to the connector is damaged).On the rest of the returned pads the flow rates were found acceptable.The flow rate for this product must be above 2.4 l/min m2.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a fullpad kit.¿.

Event Description

It was reported that the device received an alarm 01 and 02.The complainant checked the connection between the gel pad and the fluid delivery line and tried to reconnect, however there was no improvement.

• Brand Name: ARTICGEL PADS
• Type of Device: ARCTIC SUN GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 7437786
• MDR Text Key: 105929656
• Report Number: 1018233-2018-01236
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 317-03
• Device Lot Number: NGBW2264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/17/2018
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1