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

Model Number HNICU-200

Device Problem Difficult or Delayed Activation (2577)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/06/2018

Event Type  malfunction  

Event Description

While treating a newborn infant, the transport mattress (deroyal hnicu-200) failed to activate.

Event Description

While treating a newborn infant, the transport mattress (deroyal hnicu-200) failed to activate.

• Brand Name: INFANT TRANSPORT MATTRESS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 7243505
• MDR Text Key: 99088634
• Report Number: 7243505
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 01/31/2018

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
• Device Operator: Other
• Device Model Number: HNICU-200
• Device Catalogue Number: HNICU-200
• Device Lot Number: 0100749756257046
• Other Device ID Number: 74-20053
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/31/2018
• Event Location: Home
• Date Report to Manufacturer: 01/31/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR