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

Device Problems Inaccurate Flow Rate (1249); Protective Measures Problem (3015)

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 the arctic sun device had been getting low flow alerts.The nurse changed the pads, and stated they were too large for the patient.With the new pads, the flow rate was 3.0l/min.

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿low flow due to tubes are not fully connected to port barbs¿.A potential root cause for this failure could be "incorrect machine set up".Additionally, an incorrect arctic gel pad was used for the patient, indicating a potential failure mode of "incorrect product selection" and a potential root cause of "incorrect size selected" the lot number is unknown; therefore, the device history record could not be reviewed.The product code for this z300-unknown articgels pads product is unknown.Therefore, bd is unable to determine the associated labeling to review.Although the product code is unknown, the z300-unknown articgels pads product labeling is found to be adequate based on past reviews.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the arctic sun device had been getting low flow alerts.The nurse changed the pads, and stated they were too large for the patient.With the new pads, the flow rate was 3.0l/min.

• 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: 9580657
• MDR Text Key: 179243883
• Report Number: 1018233-2020-00240
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• 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: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1