MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. HYDRO-TEMP ACRYLIC; WARMER, INFANT RADIANT

Model Number	HNICU-05
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the root cause was unable to be determined due to inconsistencies with the lot number reported, and the product specified in the complaint.It is possible the wrong product was ordered, but this is unable to be confirmed due to the lack of a sample available for review.Corrective action: due to the investigation findings, a corrective action has not been taken.Investigation summary: an internal complaint ((b)(4)) was received indicating that a neonatal temperature probe cover (hnicu-05) was falling off of the patient's skin, causing irregular temperature readings.A sample was not available for return.The affected lot number was reported as 51995976.The complaint investigator reviewed the reported lot number and found that the part number associated with this lot was hnicu-03, not hnicu-05.Hnicu-03 contains a hydrogel adhesive whereas the reported part, hnicu-05, contains an acrylic adhesive.From august 2019 to present, deroyal has sold (b)(4) units of hnicu-05 and received only 1 complaint for this product, which equates to a complaint-to-sales ratio of (b)(4).Deroyal will continue to monitor post-market feedback.The investigation is complete at this time.If any new or critical information is received, this report will be updated.
Event or Problem Description
The temperature probe cover does not fit well on infant's skin.It easily falls off, and does not regulate temperature appropriately, which causes infants to run hot or cold.

• Brand Name: HYDRO-TEMP ACRYLIC
• Common Device Name: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• MDR Report Key: 10585710
• Report Number: 1034876-2020-00001
• Device Sequence Number: 3028731
• Product Code: FMT
• UDI-Device Identifier: 50749756166336
• UDI-Public: 50749756166336
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K925006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2020

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-05
• Device Lot Number: 51995976
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1