MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, LTD. FISHER & PAYKEL MYAIRVO 2 CIRCUIT; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Device Problems Device Alarm System (1012); Crack (1135); Melted (1385); Device Emits Odor (1425); Temperature Problem (3022)

Patient Problem Cough (4457)

Event Date 02/15/2023

Event Type  Injury  

Event Description

Phone call received from intake at 0100 regarding pt (patient) with burning circuit.Talked w/ (with) mom, (b)(6), who stated that she smelled burning plastic but had assumed it was neighbor, d/t (due to) them having window open earlier in night.(b)(6) went into pt (patient) room and noticed that circuit proximal to pt (patient) was cracked.She asked husband to watch pt (patient) as she went down to get new circuit.When she came back with new circuit, husband had stated that circuit was melted to the bed sheet.Parents unhooked from airvo unit.Mom stated that she unhooked pt (patient) from unit.Also, mom stated that the circuit felt very hot.(b)(6), rt (respiratory therapist) went out with new circuit and new airvo to exchange.Unit exchanged with matching settings as per rx (prescription).Once airvo warmed and ready, hooked pt (patient) back up to circuit.Watched pt (patient) and discussed episode with mom.She stated that the machine never alarmed, she only went into ava's room because of burnt plastic smell.Verified that water was in canister, and that nothing was completely covering circuit.The pt (patient) sleeps in full size bed over to the left side, circuit was laying on sheet.Made a melted coil imprint on bedding.There was a little melted circuit on a blanket nearby, but nothing was covered.Educated mom to call md (medical doctor) in morning to explain what had happened.Mom said she would follow up and notify me of any questions/concerns.Pt o2 sats (patient oxygen saturation) and hr wnl (heart rate within normal limits) before leaving.Mom called in afternoon to let me know that pt (patient) had developed a cough and when she notified her pulmonologist, dr.(b)(6), they expressed that continue to watch the cough.Event escalated to (b)(6), mgr (manager) and incident report done.Equipment bagged along with circuit and put under equipment area desk.Did take pictures and emailed to (b)(6), mgr (manager).Reference report: mw5117503.

• Brand Name: FISHER & PAYKEL MYAIRVO 2 CIRCUIT
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, LTD.; NZ
• MDR Report Key: 16929619
• MDR Text Key: 315322657
• Report Number: MW5117504
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 18 KG
• Patient Ethnicity: Hispanic