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

Catalog Number UNKNOWN

Device Problems Display or Visual Feedback Problem (1184); Inaccurate Flow Rate (1249)

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 there was low flow on the arctic sun device.The nurse was getting alert 02.Flow rate was zero, initial inlet pressure was -0.9psi, system hours were 2276 and pump hours were 1914.She already changed the initial device.Ms&s asked if the patient had gone anywhere with pads on.Nurse stated that the patient went to (b)(6), but she was unsure if the pads were in place.Because she was on a time crunch she elected to replace the pads.

Event Description

It was reported that there was low flow on the arctic sun device.The nurse was getting alert 02.Flow rate was zero, initial inlet pressure was -0.9psi, system hours were 2276 and pump hours were 1914.She already changed the initial device.Ms&s asked if the patient had gone anywhere with pads on.Nurse stated that the patient went to ct, but she was unsure if the pads were in place.Because she was on a time crunch she elected to replace the pads.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be, "belt temperatures too low after nip roller and heated section." the lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling review due to unknown product code.Although the product family was unknown, the arctic gel pad product ifus were found to be adequate based on past reviews.Corrections: d10, h3.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.

• Brand Name: UNKNOWN ARCTICGEL PADS
• Type of Device: UNKNOWN ACTIC GEL PADS
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; louisville CO 80027
• MDR Report Key: 10543319
• MDR Text Key: 208105175
• Report Number: 1018233-2020-05974
• 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: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1