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

Model Number MR850JHU

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 09/15/2020

Event Type  malfunction  

Event Description

Fisher and paykel external heater/humidifier exhibited visible smoke and smell.Error e20 was displayed on the equipment.No harm to patient.Fda safety report id# (b)(4).

• Brand Name: FISHER AND PAYKEL EXTERNAL HEATER/HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.
• MDR Report Key: 10628185
• MDR Text Key: 210002475
• Report Number: MW5097056
• Device Sequence Number: 1
• Product Code: BTT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• 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: 080205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• 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