MAUDE Adverse Event Report: PRECISION MEDICAL, INC. PRECISION MEDICAL OXYGEN BLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number PM5300

Device Problems Fire (1245); Melted (1385)

Patient Problem Insufficient Information (4580)

Event Date 03/28/2021

Event Type  Injury  

Event Description

Evening of (b)(6) 2021.There was an newborn placed into the infant warmer in the nicu for examination and a x-ray.The warming head was turned to the side to allow the x-ray unit access to the infant.The infant was immediately removed from the warmer and placed back into another warming unit, and taken back to the mothers room.The infant warmer in the nicu was left turned on and in skin sensing mode, which caused the element to ramp up to 100% power output.The warming head was also left in the turned position directly over top of an oxygen blender.Approx 4 hours later the oxygen blender melted down and burst into flames.The pressure from the o2 escaping from the damaged blender shot burning plastic and molten aluminum at the wall behind both units.The items that were on the wall then also ignited.The fire alarm did sound.Hospital staff did respond and act appropriately, extinguishing the fire with 3 - 10lb abc extinguishers.The entire ob department, both moms and babies, were evacuated to others parts of the building.The fire department responded, they checked for fire extension and ventilated smoke from the affected areas.The pa state police fire marshal and the pa doh were both notified.Fda safety report id# (b)(4).

• Brand Name: PRECISION MEDICAL OXYGEN BLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): PRECISION MEDICAL, INC.
• MDR Report Key: 11627862
• MDR Text Key: 244209753
• Report Number: MW5100580
• Device Sequence Number: 1
• Product Code: BZR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/06/2021

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
• Device Operator: Health Professional
• Device Model Number: PM5300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2021
• 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): Required Intervention