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

Model Number	HNICU-03
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; and no lot number was provided from customer; therefore, we were not able to complete a thorough investigation.Failure mode and affects analysis (fmea) was reviewed and confirmed the identified issue under investigation (probe cover lifting and unstable temperature reading).Material in deroyal's manufacturing inventory facility was examined and no discrepancies were identified.Review of material inventory in deroyal manufacturing facility was examined of current products being assembled and no discrepancies were identified.(b)(4).The 3 events reported were all related to the same issue and reported at the same time from a single customer.It could be determined that "the issue reported is due to error occurring during shipping or handling.Exposure to excessive heat or sunlight can cause the adhesive to lose effectiveness and cause temporary fluctuating or unstable readings".Deroyal's manufacturing facility already monitors controlled humidity and temperature readings on controlled storage room.The investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.
Event or Problem Description
The probe cover is not sticking to the patient around the probe, causing it to lift under the cover.There was an elevated temperature of 99.8°f to 100.3°f, however the giraffe was reading cooler temperatures of 97.8°f-98.0°f.

• Brand Name: HYDRO-TEMPERATURE COVER WITHOUT FOAM
• Common Device Name: WARMER, INFANT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• MDR Report Key: 12582529
• Report Number: 1034876-2021-00004
• Device Sequence Number: 16966220
• Product Code: FMT
• UDI-Device Identifier: 00749756255608
• UDI-Public: 00749756255608
• Combination Product (Y/N): Y
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1