MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS; ARCTIC GEL PAD

Catalog Number 318-02

Device Problems Inaccurate Flow Rate (1249); Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2021

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 flow rate of the newborn cooling pad was less than 0.5l, and the body temperature cannot be controlled.The flow rate at the start of use was 0.9 l, and then gradually decreased below 0.5 l, and the water temperature did not rise and replaced it with another pad.A complaint was received from the hospital as a defective product.The latest newborn baby cooling pad purchase history is 3 on (b)(6) 2020.

Manufacturer Narrative

The reported event was confirmed as a design related.Visual inspection of the returned sample noted one neonatal pad was received with the original packaging.Visual evaluation noted the pad line on that points towards the exterior of the pad was noted to be kinked.The root cause for this failure mode was due to diet task analysis filled out incorrectly due to inadequate directions and misunderstanding of user interface or inadequate procedure either through diet or usability which provides minimum instruction for evaluating the user interface changes to existing products or inadequate design verification testing which failed to evaluate the functionality in all the use cases (both the connector orientations) and all the affected products (neonatal pads were not tested).The product was used for treatment purposes.The product did not meet the specifications and was influenced by the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Per investigation a labeling review was not required.H11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.

Event Description

It was reported that the flow rate of the newborn cooling pad was less than 0.5 l and the body temperature could not be controlled.The flow rate at the start of use was 0.9 l and then gradually decreased below 0.5 l and the water temperature did not rise and replaced it with another pad.The complaint was received from the hospital as a defective product.The latest newborn baby cooling pad purchase history was 3 on 2020 (b)(6).

• Brand Name: ARCTIC SUN® TEMPERATURE MANAGEMENT SYSTEM, ARCTICGEL¿ PADS
• Type of Device: ARCTIC GEL PAD
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12094585
• MDR Text Key: 259234428
• Report Number: 1018233-2021-03942
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 318-02
• Device Lot Number: NGDZ4215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other