MAUDE Adverse Event Report: NECTAR PRODUCT DEVELOPMENT BREATHDIRECT BDR-19; CONTINUOUS VENTILATOR, MINIMAL VENTILATORY SUPPORT

Device Problems Device Alarm System (1012); Output Problem (3005); Pressure Problem (3012); Reset Problem (3019)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2021

Event Type  Injury  

Event Description

Breathdirect bdr-19 use for covid-19 under emergency use authorization (eua): event reported to nectar product development (eua holder) on (b)(6) 2021 and company met same-day with hospital team.Patient who is a long-term ventilator user was identified as a good candidate for use of the bdr-19 ventilator.The nurses discontinued the use of the original ventilator and switched the patient to the bdr-19 ventilator.Nurses had input the settings in the bdr-19 ventilator as cmv- mode with respiratory rate of 16, tidal volume 400, i:e ratio to 1: 2, sensitivity set to -2, peep set to 5, inspiratory pressure set to 30.The nurse described placing the patient on for two minutes and everything was normal, then the next two minutes there was a high pressure alarm.The patient was checked by the nurse and everything was normal, no coughing or sounds of discomfort.The nurse tried to troubleshoot but could not silence alarms on ventilator.The nurse noted that the device would not reset.The ventilator stopped working and froze as the nurse described it wouldn't give the patient a breath.The nurse also expressed that she had to fully turn knobs on the ventilator and power button on the ventilator to stop the alarms.The nurse pressed the silence at the top of the ventilator, unplugged patient, also held button at the top of the ventilator when alarm silenced but could not get the ventilator to stop the alarms, when there was no chest rise from the patient, the nurse decided that it was time to take patient off of the ventilator.The nurse then took patient off of the bdr-19 ventilator and provided patient with alternative original ventilator.Nectar inquired about the status of the patient and the nurse also confirmed that the patient was stable as of (b)(6) 2021.Nectar reached-out several times via phone and email for any further updates on the patient and no response was received.During the debrief with the hospital on (b)(6) 2021, nectar product development explored potential user errors related to the alarm and/or initial tidal volume settings and/or knob adjustments on the device.The team was unclear if there was a user error leading to alarm and pressure problem.The nectar and breathdirect combined team visited the hospital.An additional investigation jointly with the hospital biomed team was performed on october 4, 2021.During the investigation, engineers could not replicate the alarm from the event or the loss of pressure.Regulatory/quality requested that breathdirect, nectar and evolve manufacturing technologies inc.Distribute no further devices and that the hospital be instructed to not use the device until further notice.Evolve confirmed in writing no further distribution will occur.Nectar product development is completing a capa investigation.Testing and validation records pulled from august 24, 2021 confirm the device (unit (b)(4)) passed all specified tests.A device has been tested in a clinical setting in (b)(6) successfully.Nectar will look for successful capa investigation completion prior to decision to re-initiate field use and/or distribution.Fda safety report id# (b)(4).

• Brand Name: BREATHDIRECT BDR-19
• Type of Device: CONTINUOUS VENTILATOR, MINIMAL VENTILATORY SUPPORT
• Manufacturer (Section D): NECTAR PRODUCT DEVELOPMENT; 1332 gladys ave; long beach CA 90804
• MDR Report Key: 12614989
• MDR Text Key: 276389800
• Report Number: MW5104494
• Device Sequence Number: 1
• Product Code: MNT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention