MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED MR850 HEATED HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number MR850

Device Problems No Fail-Safe Mechanism (2990); Excessive Heating (4030)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 04/14/2023

Event Type  malfunction  

Event Description

Patient on high flow nasal cannula, fischer & paykel heater kept alarming, despite multiple interventions by respiratory therapist (rt) on a patient who was struggling to breathe.Registered nurse (rn) reached down to silence alarm and when doing so burned the tips of three fingers on the heater plate which is exposed at the top.(apparently they are all this way).Wanted to point out the fire and burn risk this presents.The unit was switched out by rt after this for safety reasons but it appears the units are all the same - the metal is exposed that touches the heating plate.If a piece of clothing or bedding was exposed to this could see a huge fire risk given the entire unit is surrounded by a lot of o2, in addition to the fact that it is so close to the silence button.No blisters formed, pain continues through the shift.

• Brand Name: MR850 HEATED HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 17400 laguna canyon road., suite 300; irvine CA 92618
• MDR Report Key: 16983270
• MDR Text Key: 315760234
• Report Number: 16983270
• 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: 05/08/2023,04/26/2023

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: Health Professional
• Device Model Number: MR850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/08/2023
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA
• Patient Sex: Female