MAUDE Adverse Event Report: BREAS MEDICAL AB VIVO 45 LS; VENTILATOR

Model Number	230000
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Breas received the devices on sep 3, 2024.The customer reported the event to breas on sep 5, 2024.The investigation started on september 17th and completed on september 26th the investigation included the following activities: visual inspection of the device, analysis of log files, functional testing.Summary of investigation: visual condition: air inlet filters were noticeably dirty.Both devices had a pungent smoke smell radiating off of it.Analysis of logs: sn: (b)(6).This is a 20min section of the treatment that was running from 00:52:06 8/9/2024 to 01:12:06 8/9/2024.Key treatment settings to note are: target volume - 700ml, max pressure - 35 cmh2o, min pressure - 14 cmh2o, high pressure alarm - 25 cmh2o.The treatment appeared to be running as intended (the target tidal volume of 700ml was consistently delivered to the patient with an average peak pressure of 15-16 cmh2o).At approximately 1:04:50, an unknown event occurred that caused the measured tidal volume delivery to drop suddenly.This type of event is commonly caused by a sudden increase in resistance.At this point, the peak inspiratory pressure was consistently measured at 25 cmh2o.The device is designed to adjust the pressure within the min and max settings to maintain the set volume of 700ml.However, in this instance, the delivered breath was terminated early secondary to the "high pressure" alarm being set at 25cmh2o.When this alarm is triggered, the device will automatically cut the breath short.Since the device calculation determined a pressure higher than 25 cmh2o was needed, it continued to hit this threshold and cut the breath short.Due to this sequence of events and combination of settings, the device was not reaching the target volume of 700ml.The device performed according to spec based on the applied settings at the time.Sn: (b)(6).This device was the second device placed on the patient.Treatment was started at 02:11:57 with the treatment settings posted in section 2.1.At this time, the device was set with a min & max pressure of 20 cmh2o.This kept the peak inspiratory pressure at a consistent level of 20 cmh2o and limited the ability of the device to adjust and to deliver the desired target volume of 700ml.At approximately 2:50:16, the device was switched to a different profile where the min pressure was set to 14 cmh2o and the max pressure was set to 35 cmh2o.The device was also set with a high-pressure alarm of 30 cmh2o.Much like the first device, the calculation called for a pressure higher than 30 cmh20 in order to deliver the desired tidal volume.Once again, the device was hitting this threshold of 30 cmh2o and cutting the breath short.Due to this sequence of events and combination of settings, the device was not reaching the target volume of 700ml.The device performed according to spec based on the applied settings at the time.Calibration: sn (b)(6) did not require calibration.Sn (b)(6) did require calibration, which was successful.Functions and alarms: sn (b)(6) passed pressure and flow verification, alarm testing, and buttons testing.No faults found with the device.Sn (b)(6) passed pressure verification but failed flow calibration for values 3000ml/sec and above.The device was recalibrated and passed flow verification.Both alarm and button testing passed.No faults found with the device.Cause: the root cause was an unknown event occurred that caused the measured tidal volume delivery to drop suddenly.The customer description of the event is consistent with the log files and settings set on both devices.We are unable to speculate exactly what event may have caused the sudden drop in tidal volume delivery.This type of event is commonly caused by a sudden increase in resistance.Risk assessment: based on the investigation results, the device operated according to specification and intended use.That said, the incorrect settings could lead to hazardous situation as assumed by the clinician who has defined the alarm limits, as the situation activated the low minute volume alarm.Alarm limits, by definition, are set and used to prevent hazardous situations to occur and warn the user/caregiver so they can take action before the situation becomes hazardous, as happened in this case.Conclusion and actions: after a full investigation into the logs and functionality of both devices, it has been determined that the devices functioned within spec based on the settings that were set during the time of the event.The high pressure alarm limit set at 25 and 35cmh2o respectively will limit the ventilator to deliver higher pressures than this alarm limit.So in the case of the device with sn (b)(6), even if max pressure is set at 35cmh2o, this value can't be reached as the pressure will be limited by the setting of the high pressure alarm limit at 25cmh2o.In case this limitation causes the tidal or minute volume not to be reached, the low tidal volume and/or low minute volume alarm should warn the user, assuming they are set correctly.This is a use error during set-up of the ventilator.For the ventilator with sn (b)(6) the screenshot of the ventilator settings in profile 1 confirm another user error as both max pressure and min pressure are set at the same level (20cmh2o) and as such do not allow to increase or decrease the applied pressure to ensure a consistent tidal volume.This can be seen on the download where the inspiratory pressure is at 20, till the moment where a red "diamond" appears in the events graph.This most likely confirms the profile change (can be checked in pcsw but not on the screen shot).Apparently, this setting conflict (max pressure = min pressure) was not the case in a different profile.The setting of the high-pressure alarm at 30cmh2o has blocked the pressure to rise above this value and a too low tidal volume delivery caused the low tidal or minute volume to sound.The investigation report will be provided to the reporter with a recommendation to inform the prescribing healthcare professional to adjust the settings to prevent recurrence of a similar situation.
Event or Problem Description
On sep 5, 2024, breas received an incident report forwarded by the healthcare provider: location of incident: home.Description of incident: patient was asleep and resting well when the ventilator started alarming low-minute ventilation.Mom went to room to see what was going on and noticed that the vent was not ventilating the patient correctly.Tidal volume was set at 700 and the ventilator was only giving 200-300 cmh2o.The second ventilator was then turned on and did the same thing.Parents want the vents removed.How was the incident detected: alarm and visual was the patient/client using the equipment at the time: yes.If yes, describe how the equipment was being used: patient was on ventilator.Was the patient/client injured: no.Was any immediate medical intervention required: yes.If yes, describe the intervention provided: manual bagging.Was there any damage to other property or equipment: no.Was the equipment removed from service: yes.If yes, where was the equipment sent: back to the rental company trace medical.Describe any immediate actions taken to secure patient safety: patient was transferred to a different ventilator.It was later added that the event was discovered by the patient's mother during the night on aug 8, 2024 at 1:59am.

• Brand Name: VIVO 45 LS
• Common Device Name: VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, vastra gotaland SE-43 533; SW SE-43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, vastra gotaland 43533 ; SW 43533
• Manufacturer Contact: ivan liljegren ; foretagsvagen 1; molnlycke, vastra gotaland 43533 ; SW 43533
• MDR Report Key: 20360307
• Report Number: 9617566-2024-00005
• Device Sequence Number: 8086432
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: (01)07321822300004(11)240410
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K193586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 230000
• Device Catalogue Number: 230016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Unknown