MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS ; PACK, HOT OR COLD, DISPOSABLE

Model Number	HNICU-200
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported through a medwatch, "when attempting to activate the chemical mattress for a preterm infant delivery, it was extremely difficult to activate.Multiple attempts were made which resulted the pillow contents spilling out of the device on to a nurse and to the operating room floor.Another mattress was obtained and it was difficult to activate but was eventually activated for use.".
Additional Manufacturer Narrative
A user facility reported through a medwatch, "when attempting to activate the chemical mattress for a preterm infant delivery it was extremely difficult to activate.Multiple attempts were made which resulted the pillow contents spilling out of the device on to a nurse and to the operating room floor.Another mattress was obtained and it was difficult to activate but was eventually activated for use." deroyal industries, inc.Requested return of the device, however it was noted it was unavailable for return.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Additional Manufacturer Narrative
A user facility reported through a medwatch, "when attempting to activate the chemical mattress for a preterm infant delivery it was extremely difficult to activate.Multiple attempts were made which resulted the pillow contents spilling out of the device on to a nurse and to the operating room floor.Another mattress was obtained and it was difficult to activate but was eventually activated for use." deroyal industries, inc.Requested return of the device, however it was noted it was unavailable for return.Deroyal reviewed the work order and specifications for the hnicu-200 and no issues were found.An inventory check was not able to be performed as no products were present at the distribution center.However, there were products in production that were inspected and found to be acceptable and meeting specifications.Four samples from two lots were tested and all samples activated appropriately.The risk analysis was reviewed and was found to be appropriate and not in need of an update.The design of the hnicu-200 has a seal with an angled chevron that directs the contents of the inner bag when squeezed to a focal point for an easier activation.A complaint to sales ratio has been conducted from january 2023 to january 2025 and found to be (b)(4).Root cause: because the sample was unavailable to be returned and no issues were found in the manufacturing processes, 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 becomes available.

• Brand Name: INFANT TRANSPORT MATTRESS
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37825
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 24085009
• Report Number: 2320762-2026-00001
• Device Sequence Number: 9776233
• Product Code: IMD
• UDI-Device Identifier: 00749756257046
• UDI-Public: 00749756257046
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980509
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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-200
• Device Lot Number: 62030791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 01/28/2026
• 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
• Patient Sex: Unknown