MAUDE Adverse Event Report: TECH TRADE LLC READY HEAT INFANT WARMING MATTRESS; BEDDING, DISPOSABLE, MEDICAL -READY-HEAT

Model Number S2RHIM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 09/12/2019

Event Type  Injury  

Event Description

The device was used to maintain the body temperature of a newborn pt that was delivered in a home setting and required transport to a local healthcare facility by ambulance.The device was placed behind the newborn shortly after arrival by first responders.The device was continued to be held in place by mother, and later father, until arrival of transport crew.The pt was then transferred to the ambulance and placed on the stretcher and restrained in an acr, or ambulance child restraint device, for approx 30 mins.The warming blanket was inside of the acr with a barrier between the blanket and the posterior of the newborn for the transport.Upon arrival at the healthcare facility, the pt was found to have a combination of full and partial thickness burns to the bilateral shoulders and the coccyx area.Total percentage of burn was initially estimated to be between 10-12%.Fda safety report id# (b)(4).

• Brand Name: READY HEAT INFANT WARMING MATTRESS
• Type of Device: BEDDING, DISPOSABLE, MEDICAL -READY-HEAT
• Manufacturer (Section D): TECH TRADE LLC ; jersey city NJ 07302
• MDR Report Key: 9130368
• MDR Text Key: 160387744
• Report Number: MW5090088
• Device Sequence Number: 1
• Product Code: KME
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: S2RHIM
• Device Lot Number: 18183M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability