MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. HYDRO-TEMP COVER W/O FOAM 7/8" ; WARMER, INFANT RADIANT

Model Number	HNICU-02
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Hyperthermia (1909)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported through a medwatch, "rn went into room to respond to the bed alarming "patient hot".Rn took infants temperature, and it read 38.6.Rn aired infant out and retook temp 30 min later.Temp 38.Rn encouraged mom to do skin to skin with infant to help regulate a normal temperature again.Mom did skin to skin and infant returned to a normal temperature.Sticker replaced at every care due to it not holding the temp probe on the infant throughout entire shift.Sticker not staying on babies and not helping the bed regulate appropriate temperature outputs." deroyal industries, inc.Requested return of the device, however it was marked as not available for return.This investigation is ongoing and not complete at this time.No further information is available at this time.We will provide follow up report when additional information is received.
Event or Problem Description
A user facility reported through a medwatch, "rn went into room to respond to the bed alarming "patient hot".Rn took infants temperature, and it read 38.6.Rn aired infant out and retook temp 30 min later.Temp 38.Rn encouraged mom to do skin to skin with infant to help regulate a normal temperature again.Mom did skin to skin and infant returned to a normal temperature.Sticker replaced at every care due to it not holding the temp probe on the infant throughout entire shift.Sticker not staying on babies and not helping the bed regulate appropriate temperature outputs.".
Additional Manufacturer Narrative
A user facility reported through a medwatch, "rn went into room to respond to the bed alarming "patient hot".Rn took infants temperature, and it read 38.6.Rn aired infant out and retook temp 30 min later.Temp 38.Rn encouraged mom to do skin to skin with infant to help regulate a normal temperature again.Mom did skin to skin and infant returned to a normal temperature.Sticker replaced at every care due to it not holding the temp probe on the infant throughout entire shift.Sticker not staying on babies and not helping the bed regulate appropriate temperature outputs." deroyal industries, inc.Requested return of the device, however it was marked as not available for return.Work orders were reviewed and no issues were identified.The certificate of analysis was reviewed and determined raw material was produced to specification.There has been no change to the raw materials or the manufacturing process.An inventory check was unable to be performed as no cases were available to be checked.A complaint to sales ratio was conducted over the past two years and found to be 0.0001%.Root cause: the investigation findings did not identify any issues that would be the cause of the malfunction.Therefore, the root cause was unable to be determined.Corrective and preventive actions: because the root cause was unable to be determined, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends around this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information is received.

• Brand Name: HYDRO-TEMP COVER W/O FOAM 7/8"
• Common Device Name: WARMER, INFANT RADIANT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 23401723
• Report Number: 1034876-2025-00002
• Device Sequence Number: 15939047
• Product Code: FMT
• UDI-Device Identifier: 00749756166317
• UDI-Public: 00749756166317
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191425
• 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,Followup
• Report Date (Section B): 03/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HNICU-02
• Device Lot Number: 62317126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown