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

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)

Event Date 05/10/2019

Event Type  malfunction  

Event Description

Respiratory therapist (rt) called to patient room because her o2 sats were dropping.Because the patient was on high flow nasal cannula (hfnc), rt decided to increase her oxygen/flow.As soon as the oxygen/flow was increased, an error message appeared on the screen saying: unplug oxygen and restart.The patient started complaining of shortness of breath (sob) and her o2 sats dropped to 80%.The patient was removed immediately from the device and placed on a 50% venti-mask.I disconnected the device and tried to restart it, but the error message remained on screen.At this time the patient oxygen levels failed to improved, so she was given oxygen therapy via manual resuscitation.The supervisor was called, and the device was removed and replaced.Manufacturer response for airvo - high flow oxygen, airvo (per site reporter): returned to the manufacturer for replacement by biomed.

• Brand Name: AIRVO
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC; 173 technology dr; irvine CA 92618
• MDR Report Key: 8678316
• MDR Text Key: 147318236
• Report Number: 8678316
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32850 DA