MAUDE Adverse Event Report: MEDLINE INDUSTRIES-ARLINGTON HEIGHTS HUDSON RCI PREFILLED HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number RHP340U

Patient Problem Nasal Obstruction (2466)

Event Date 08/04/2023

Event Type  Other  

Event Description

Patient reported her nose was dry and was on 4l high flow nasal cannula.Rn titrated patient to 3l and changed nasal cannula to regular and added humidification (discussed with rt).Rn set up new system (see below).After rn set up tubing and turned o2 to 3l, patient reported "drowning." she removed her nasal cannula, liquid from humidifier was pouring out through the nasal prongs, gown was wet, cannula was filled with water from bubbler.Patient coughing, oxygen sat stable.Patient stated she was ok.Hudson rci prefilled humidifier 340ml ,lot 23b141, ref: rhp340u, 2023-03-29, 2027-03-29, l02552 r01 (7/20) including adaptor airlife, adult cushion nasal cannula25ft nasal cannula ref: sft2625u, lot 0004225427, 2025-08-04 airlife, smooth bore oxygen tubing 7ft, ref 001330u, lot 0004209655, 2025-02-11 nasal cannula extender connector.

• Brand Name: HUDSON RCI PREFILLED HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): MEDLINE INDUSTRIES-ARLINGTON HEIGHTS
• MDR Report Key: 17499581
• MDR Text Key: 321157021
• Report Number: MW5122892
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/07/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: RHP340U
• Device Lot Number: 23B141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AIRLIFE NASAL CANNULA SFT2625U.; AIRLIFE SMOOTH BOR OXYGEN TUBING 001330U.
• Patient Age: 53 YR
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White