inforMED
MalfunctionBZR

PM5200 SERIES,BLENDER,AIR/O2,HIGH FLOW

Received Jun 24, 2022 · Event occurred May 27, 2022

Report 14799515 · MDR key 14799515

Device

Generic name

Mixer, Breathing Gases, Anesthesia Inhalation

Model number

PM5200

Product problems

  • Therapeutic or Diagnostic Output Failure

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NICU POD BEDSPACE. MULTIPLE ATTEMPTS AT CHANGING THIS PATIENT TO BUBBLE CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) FROM NIV NAVA (NONINVASIVE NEURALLY ADJUSTED VENTILATORY ASSIST) HAVE FAILED OVER THE PAST SEVERAL WEEKS. AN EQUIPMENT MALFUNCTION WAS FOUND THIS EVENING WITH THE OXYGEN BLENDER. FLOW WAS BEING GIVEN; HOWEVER, UNKNOWN WHAT THE FIO2 (FRACTION OF INSPIRED OXYGEN) WAS. ACCORDING TO THE MALFUNCTIONING BLENDER, WE WERE HAVING TO ADMINISTER 80% AND PATIENT WOULD SUBSEQUENTLY HAVE TO BE PLACED BACK TO NIV NAVA. THIS HAS OCCURRED MULTIPLE TIMES WITH THIS PATIENT. THE BLENDER IN QUESTION WAS REPLACED THIS EVENING AND THE ISSUE WAS RESOLVED. THERE APPEARED TO BE NO DETRIMENTAL OR HARMFUL EFFECTS TO THE PATIENT. ISSUE RESOLVED ON DATE REDACTED 2000HRS.

Description of Event or Problem

NICU POD BEDSPACE. MULTIPLE ATTEMPTS AT CHANGING THIS PATIENT TO BUBBLE CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) FROM NIV NAVA (NONINVASIVE NEURALLY ADJUSTED VENTILATORY ASSIST) HAVE FAILED OVER THE PAST SEVERAL WEEKS. AN EQUIPMENT MALFUNCTION WAS FOUND THIS EVENING WITH THE OXYGEN BLENDER. FLOW WAS BEING GIVEN; HOWEVER, UNKNOWN WHAT THE FIO2 (FRACTION OF INSPIRED OXYGEN) WAS. ACCORDING TO THE MALFUNCTIONING BLENDER, WE WERE HAVING TO ADMINISTER 80% AND PATIENT WOULD SUBSEQUENTLY HAVE TO BE PLACED BACK TO NIV NAVA. THIS HAS OCCURRED MULTIPLE TIMES WITH THIS PATIENT. THE BLENDER IN QUESTION WAS REPLACED THIS EVENING AND THE ISSUE WAS RESOLVED. THERE APPEARED TO BE NO DETRIMENTAL OR HARMFUL EFFECTS TO THE PATIENT. ISSUE RESOLVED ON [DATE REDACTED] 2000HRS.