MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 45 LS; EXTRA HOSPITAL PORTABLE VENTILATORS

Model Number VIVO 45 LS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Respiratory Arrest (4461); Insufficient Information (4580)

Event Date 02/19/2023

Event Type  Death  

Manufacturer Narrative

On (b)(6) 2023, breas medical ab received information that vivo 45 ls s/n (b)(4) had been involved in an incident that happened in (b)(6) hospital ventilatordepartment, (b)(6).The patient involved in the incident has unfortunately expired.As to this date we do not have additional information about the exact date and time of the event nor any additional information about the context of the incident.An inquiry has been made in order to get the log files and the device so a technical analysis can be started and a root cause can be established.

Event Description

On (b)(6) 2023, breas medical ab received information that vivo 45 ls s/n (b)(4) had been involved in an incident that happened in the (b)(6) hospital ventilatordepartment, (b)(6).The patient involved in the incident has unfortunately expired.As to this date we do not have additional information about the exact date and time of the event nor any additional information about the context of the incident.An inquiry has been made in order to get the log files and the device so a technical analysis can be started and a root cause can be established.

Manufacturer Narrative

On february 23, 2023, breas medical ab received information that vivo 45 ls s/n (b)(6) had been involved in an incident that happened in the astrid lindgrens child hospital ventilatordepartment, stockholm.The patiennt involved in the incident has unfortunately expired.As to this date we do not have additional information about the exact date and time of the event nor any additional information about the context of the incident.An inquiry has been made in order to get the log files and the device so a technical analysis can be started and a root cause can be established.Update 2023-03-10: 1.Background: on february 23, 2023, breas medical ab received information that vivo 45 ls s/n (b)(6) had been involved in an incident that happened in the (b)(6).The patient involved in the incident was found dead in the morning of (b)(6) 2023 and is believed to have passed away between 6 and 9 am, according to the hospital.The device vivo 45 ls s/n (b)(6) was manufactured in october 2021 and released to the market on november 4, 2021.2.Investigation: this investigation only consists of an analysis of the log files that have been downloaded from the device and sent to breas, courtesy of astrid lindgren's child hospital.Any conclusion in this report is drawn only from the information stored in the device's memory and history log.2.1 analysis of device log files: analysis of the log files was made by breas using the breas pc software (ref.(b)(4), version 1.2.10).The oldest data (level 1 data) in the device memory was from november 2021, but the first patient treatment (level 2 data) seems to have started in (b)(6) 2022, and the device had been upgraded to a newer firmware 3.1.7 in september 2022.Detailed data (level 3 data) were available for the period of 16 to 19 february.There were no technical or physiological alarms registered in the log at all during this detailed period (16 - 19 feb.).The device was run in pediatric psv mode with a leakage circuit and epap 4 cmh2o and inspiratory pressure 10 cmh2o, with inspiratory and expiratory triggers set to 2, the second most sensitive setting.The backup breath rate was set to 20 breaths per minute.All treatment sessions in this period were run on mains power.The final treatment session on the day of the incident took place from 04:38:38 on (b)(6)until 10:22:48 according to the time stamps in the log.All previous treatment sessions in the device memory, including the start of the final session, show a mixture of patient triggered breaths and machine triggered breaths, according to the settings described above.The machine triggered breaths appear every 3 seconds unless there is a respiratory effort made by the patient.Machine triggered breaths can be seen as yellow or orange portions of the spontbreath bar, see appendix.Patient triggered breaths are shown in dark green and may appear at a breath rate generated by the patient that is higher than 20 bpm.About 30 minutes into the final session, a period with almost only machine triggered breaths occur, and lasts for about 10 minutes.During these 10 minutes the device delivers ventilation at the set parameters, 10/4 cmh2o at the backup rate 20 bpm, and the delivered volume (vt bar in appendix) drops significantly but not completely.Normal behavior, with mixed patient triggered and machine triggered breaths, is resumed for about 1 hour and 15 minutes.Then, at around 6:47 in the morning of february 19, all patient triggered breaths disappear in the log file, until treatment is manually stopped at 10:22 and patient presumably disconnected.During this whole time, the device again delivers ventilation at the set parameters, 10/4 cmh2o at the backup rate 20 bpm, but with very low volume delivered to the patient.No alarms are given during this period since no alarm trigger levels are reached, the low volume alarm was set to off.3.Conclusions: in conclusion, analysis of the log files of the device (b)(6) involved in an incident on (b)(6) 2023 does not provide any indications that the device has caused or contributed to the incident.According to the log files, this device has delivered ventilation to a patient with the set parameters until manually shut down after the incident.There is no sign of any malfunction and there are no technical or functional failures registered in the device memory.No physiological alarms were triggered when the patient's spontaneous breathing ceased, since no set alarm conditions were fulfilled.In conclusion, the device has acted as intended and according to its design specifications during this unfortunate incident.

Event Description

On february 23, 2023, breas medical ab received information that vivo 45 ls s/n (b)(6) had been involved in an incident that happened in the (b)(6) hospital ventilatordepartment, stockholm.The patiennt involved in the incident has unfortunately expired.As to this date we do not have additional information about the exact date and time of the event nor any additional information about the context of the incident.An inquiry has been made in order to get the log files and the device so a technical analysis can be started and a root cause can be established.Update 2023-03-10: 1.Background on february 23, 2023, breas medical ab received information that vivo 45 ls s/n (b)(6) had been involved in an incident that happened in the (b)(6).The patient involved in the incident was found dead in the morning of (b)(6), 2023 and is believed to have passed away between 6 and 9 am, according to the hospital.The device vivo 45 ls s/n (b)(6) was manufactured in october 2021 and released to the market on november 4, 2021.2.Investigation this investigation only consists of an analysis of the log files that have been downloaded from the device and sent to breas, courtesy of (b)(6) hospital.Any conclusion in this report is drawn only from the information stored in the device's memory and history log.2.1 analysis of device log files: analysis of the log files was made by breas using the breas pc software (ref.(b)(4), version 1.2.10).The oldest data (level 1 data) in the device memory was from november 2021, but the first patient treatment (level 2 data) seems to have started in (b)(6) 2022, and the device had been upgraded to a newer firmware 3.1.7 in september 2022.Detailed data (level 3 data) were available for the period of 16 to 19 february.There were no technical or physiological alarms registered in the log at all during this detailed period (16 - 19 feb.).The device was run in pediatric psv mode with a leakage circuit and epap 4 cmh2o and inspiratory pressure 10 cmh2o, with inspiratory and expiratory triggers set to 2, the second most sensitive setting.The backup breath rate was set to 20 breaths per minute.All treatment sessions in this period were run on mains power.The final treatment session on the day of the incident took place from 04:38:38 on (b)(6) until 10:22:48 according to the time stamps in the log.All previous treatment sessions in the device memory, including the start of the final session, show a mixture of patient triggered breaths and machine triggered breaths, according to the settings described above.The machine triggered breaths appear every 3 seconds unless there is a respiratory effort made by the patient.Machine triggered breaths can be seen as yellow or orange portions of the spontbreath bar, see appendix.Patient triggered breaths are shown in dark green and may appear at a breath rate generated by the patient that is higher than 20 bpm.About 30 minutes into the final session, a period with almost only machine triggered breaths occur, and lasts for about 10 minutes.During these 10 minutes the device delivers ventilation at the set parameters, 10/4 cmh2o at the backup rate 20 bpm, and the delivered volume (vt bar in appendix) drops significantly but not completely.Normal behavior, with mixed patient triggered and machine triggered breaths, is resumed for about 1 hour and 15 minutes.Then, at around 6:47 in the morning of (b)(6), all patient triggered breaths disappear in the log file, until treatment is manually stopped at 10:22 and patient presumably disconnected.During this whole time, the device again delivers ventilation at the set parameters, 10/4 cmh2o at the backup rate 20 bpm, but with very low volume delivered to the patient.No alarms are given during this period since no alarm trigger levels are reached, the low volume alarm was set to off.3.Conclusions: in conclusion, analysis of the log files of the device k400122 involved in an incident on (b)(6) 2023 does not provide any indications that the device has caused or contributed to the incident.According to the log files, this device has delivered ventilation to a patient with the set parameters until manually shut down after the incident.There is no sign of any malfunction and there are no technical or functional failures registered in the device memory.No physiological alarms were triggered when the patient's spontaneous breathing ceased, since no set alarm conditions were fulfilled.In conclusion, the device has acted as intended and according to its design specifications during this unfortunate incident.

• Brand Name: BREAS VIVO 45 LS
• Type of Device: EXTRA HOSPITAL PORTABLE VENTILATORS
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer Contact: gabriel vasiliu ; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 16477317
• MDR Text Key: 310592623
• Report Number: 9617566-2023-00002
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K193586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

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
• Device Model Number: VIVO 45 LS
• Device Catalogue Number: 230000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 02/23/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death