MAUDE Adverse Event Report: PRECISION MEDICAL BLENDER; PM5300 BLENDER

Model Number PM5300

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2021

Event Type  Injury  

Manufacturer Narrative

Precision medical blender involved in fire; however was not the source of the incident as investigated by the health care facility as described below."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".The oxygen blender was model# pm5300.S/n was destroyed in the fire.Precision medical reviewed previous complaint files and maude database which confirmed no other similar incidents or trending of the nature of the incident.At this time, there is no further information.Should additional information pertaining to the incident become available, a follow-up report will be filed.It is unknown at this time if the blender can be returned for evaluation.

Event Description

Fire involving precision medical blender caused by a heating element head of the warmer as described in the narrative.

Manufacturer Narrative

Corrected b2 and h1 from orginal report pm5300-2523148-2021-0001 reference user facility report no (mw5100580).Precision medical blender involved in fire; however was not the source of the incident as investigated by the health care facility as described below."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" the oxygen blender was model# pm5300.S/n was destroyed in the fire.Precison medical reviewed previos complaint files and maude database which confirmed no other similar incidents or trending of the nature of the incident.At this time, there is no further information.Should addtional information pertaining to the incident become available, a follow-up report will be filed.It is unknown at this time if the blender can be returned for evaluation.

Event Description

Fire involving precision medical blender caused by a heating element head of the warmer as described in the narrative.

• Brand Name: PRECISION MEDICAL BLENDER
• Type of Device: PM5300 BLENDER
• MDR Report Key: 11633153
• MDR Text Key: 244371080
• Report Number: 2523148-2021-00001
• Device Sequence Number: 1
• Product Code: BZR
• UDI-Device Identifier: 00855887006016
• UDI-Public: 00855887006016
• Combination Product (y/n): N
• PMA/PMN Number: K053232
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

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
• Device Operator: Health Professional
• Device Model Number: PM5300
• Device Catalogue Number: PM5300
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention