MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. HYDRO-TEMP COVER WITHOUT FOAM; WARMER, INFANT RADIANT

Model Number	HNICU-03
Medical Device Problem Codes	Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the root cause was unable to be determined.A potential root cause of improper skin preparation has been identified.The instructions for use packaged with the product include a step to prep the skin by removing body oils and hair prior to probe cover application.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint ((b)(4)) was received for a neonatal probe cover (finished good hnicu-03, lot 50305961) that failed to adhere to the skin, resulting in unstable temperature readings.One sample was returned december 17, 2019, for evaluation.The sample was reviewed for visual and adhesive qualities.No discrepancies were identified.The cover was placed in different areas of the hand and arm.Each time the cover was removed and replaced; the device properly adhered to the skin.Quality records for the reported lot were reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.Certificates of analysis for the raw materials also were reviewed and all were found to be within specification.The instructions for use packaged with the product include a step for skin preparation prior to applying the probe cover.The ifu also includes direction that, after applying the probe cover to the skin several times, it may be necessary to replace with a new probe cover.From 2017 to present, deroyal has sold (b)(4) cases of the product.There have been no like complaints during this same time period.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
When the temp sensor is used on the micro-preemie population, the pad is sliding.The gel on the back loses its "sticky" property, which causes the device to not stick to the skin.The nurses are reporting unstable temperatures in that population.

• Brand Name: HYDRO-TEMP COVER WITHOUT FOAM
• Common Device Name: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• MDR Report Key: 9570128
• Report Number: 1034876-2019-00002
• Device Sequence Number: 16225205
• Product Code: FMT
• UDI-Device Identifier: 50749756255603
• UDI-Public: 50749756255603
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K925006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: HNICU-03
• Device Lot Number: 50305961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1