MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. VENTILATOR HEATER HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number MR850JHU

Device Problem Device Emits Odor (1425)

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

Event Date 11/10/2021

Event Type  malfunction  

Event Description

Infant being treated in the nicu for prematurity and respiratory failure requiring mechanical ventilation.Pulmonary therapist noted a warm smell coming from the heating unit used to warm and humidify the air that passes through the ventilator.Heating unit removed from service and sent to biomedical engineering.New pulmonary heating unit placed into service.No harm to patient.Fda safety report id # (b)(4).

• Brand Name: VENTILATOR HEATER HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.
• MDR Report Key: 12883122
• MDR Text Key: 281517179
• Report Number: MW5105620
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2021

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: MR850JHU
• Device Catalogue Number: MR850JHU
• Device Lot Number: 071211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Male
• Patient Weight: 1 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White