MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED FISHER PAYKEL HEALTHCARE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Lot Number 2100069412

Device Problems Leak/Splash (1354); Use of Device Problem (1670); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 07/29/2021

Event Type  malfunction  

Event Description

Fisher & paykel myairvo 2 humidifier knocked over (not clear how hard) and fell off flat pedestal.Maybe pegs not holding as well as other machines we have.So machine turned on its side and then water leaked, could not use.

• Brand Name: FISHER PAYKEL HEALTHCARE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 173 technology dr; suite 100; irvine CA 92618
• MDR Report Key: 12646880
• MDR Text Key: 276877614
• Report Number: 12646880
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/28/2021

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: No Information
• Device Lot Number: 2100069412
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2021
• Date Report to Manufacturer: 10/18/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29200 DA