PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
Recall
- Recall Number
- Z-3262-2024
- Event Number
- 95173
- Firm
- Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand
- FEI Number
- 3002806988
- Product Code
- QAV
- Status
- Open, Classified
- Root Cause
- Software change control
- Initiated
- August 7, 2024
- Posted
- September 25, 2024
Description
PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.
On 08/13/2024, the firm sent an "Urgent: Medical Device Correction" Letter via email, phone, letter or face to face communication to inform customers that due to a software issue with the Airvo 3 (software version 1.5.1 or earlier) when the flow alignment alarm 3.2.2 occurs, Airvo 3 devices set up with high pressure oxygen the device will deliver room air only. Patients may experience oxygen desaturation that could lead to hypoxia. For Distributors - Actions required for affected products are: Step1-Identify affected products using Model Number reference (REF), Serial Number (SN) and Manufacturing Date (YYYY-MM-DD). If the device is still within your inventory, put the product in quarantine to prevent ongoing distribution until Fisher&Paykel (F&P) Healthcare has contacted you with next steps. Step2-Complete and return the attached response form Step3-Await instructions from Fisher&Paykel Healthcare For healthcare facilities: Until the software is updated, the Airvo 3 device can continue to be used by your customers. When using the device, all instructions, including warnings and cautions in the Airvo 3 User Manual must be followed, particularly those in Sections 1 and 2. If alarm 3.2.2 occurs, follow the onscreen instructions. For questions/assistance - contact F&P Field Action Team via email at [email protected] or directly at +1 (800) 446 3908 ext 5003 or +1 (949) 453 4000 ext 5003.
U.S.: AZ, CA, CO, CT, DC, FL, GA, IA, IL, KY, MA, MD, MI, MN, MO, MT, ND, NH, NJ, NV, NY, OH, OR, PA, SD, TX, UT, VA and WA. O.U.S.: Not provided
944 units