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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2022

Event Type  malfunction  

Event Description

Humidification system for the ventilator became non--nonfunctional, required rt to troubleshoot.Fda safety report id# (b)(4).

• Brand Name: F/P HEATER VENTILATOR HUMIDIFICATION
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.
• MDR Report Key: 13652403
• MDR Text Key: 286526498
• Report Number: MW5107818
• 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: 02/28/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2022
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male