MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC V60 PLUS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE

Model Number 1138747

Device Problems Device Emits Odor (1425); Obstruction of Flow (2423); Protective Measures Problem (3015); Lack of Effect (4065)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/02/2022

Event Type  malfunction  

Event Description

Situation: bedside rn called me to assist due patient complaint of not getting enough air from bipap, pt also stated there was a burning smell, patient minor desat to low 90's when was previously mid to high 90's and stating a red alarm has been continuously appearing.Background: patient has been on v60 bipap since respiratory therapist (rt) have received the patient with no previous trouble.Rt was called to bedside to assess patient and the v60.Assessment: when rt arrived to room noticed the v60 was alarming red "low leak - co2 rebreathing risk" --> confirmed pt was doing okay and asked what was going on/how she is feeling.Pt stated she feels like the machine isn¿t giving enough air anymore and that there is a burning smell coming from the mask.Immediately decided to change the whole v60 for a new machine as it is not normal.After changing to the new v60 and a new mask with the exact same settings, patient stated it feels a lot better and she does not smell the burning smell anymore.While taking the old v60 out of the room and to inform biomed did notice that the filter on the back was clogged with a lot of dust and there was a slight burnt smell coming from the machine.Recommendation: instead of just monthly circuit changes rt thinks it is important that if a patient is on any particular modality for an extended period of time the machine should be changed out completely, replaced with a new one and the old machine should broken down/cleaned properly including the back filters (rt's do not have access to take off the back filter as it has a lock, nor are there readily available filters for us to change the filter) machine is being evaluated by biomed.There was no harm to patient in this event.

• Brand Name: V60 PLUS
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
• Manufacturer (Section D): RESPIRONICS CALIFORNIA, LLC; 2271 cosmos ct; carlsbad CA 92011
• MDR Report Key: 15968745
• MDR Text Key: 305347623
• Report Number: 15968745
• Device Sequence Number: 1
• Product Code: MNT
• 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: 12/07/2022

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 Model Number: 1138747
• 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: 12/07/2022
• Date Report to Manufacturer: 12/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5840 DA
• Patient Sex: Female