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

Model Number PT101US

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Fisher & paykel healthcare airvo 2 humidifier stopped working.

Event Description

Fisher & paykel healthcare airvo 2 humidifier stopped working after power was switched onto the backup generator during testing would not correct after turn off and on.The patient's oxygen levels dropped significantly while the problem was sorted out and a new device was obtained.No other devices behaved in this manner.The outlet was tested and fund to be in working order.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER PAYKEL HEALTHCARE LIMITED; 173 technology dr; irvine CA 92618
• MDR Report Key: 11919325
• MDR Text Key: 253754761
• Report Number: 11919325
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

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 Model Number: PT101US
• Device Catalogue Number: PT101US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2021
• Date Report to Manufacturer: 06/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Female