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

Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

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 displayed an alarm 53 and alert 52.The flow rate was low, as only two pads were attached.It was later reported the patient's therapy was discontinued since she was able to maintain normothermia.

Manufacturer Narrative

The reported event was confirmed use-related.No sample was returned for evaluation.The failure mode is '1.1 incorrect product selection effect i: prolongation of therapy¿ with the root cause of '1.1.1 use of incomplete set.¿ the lot number is unknown; therefore, the device history record could not be reviewed.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.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 displayed an alarm 53 and alert 52.The flow rate was low, as only two pads were attached.It was later reported the patient's therapy was discontinued since she was able to maintain normothermia.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 9489913
• MDR Text Key: 179262345
• Report Number: 1018233-2019-08061
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• 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: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1