MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V600; VENTILATORS, INTENSIVE CARE

Catalog Number 8422300

Device Problems Use of Device Problem (1670); Failure to Deliver (2338); No Apparent Adverse Event (3189)

Patient Problem Respiratory Arrest (4461)

Event Date 03/05/2022

Event Type  Injury  

Event Description

It was reported that during a transport of an intubated-ventilated patient at approximately 10:00 a.M., a low battery message from the ventilator occurred after approximately 10 minutes.The device was then reconnected to the power supply.After another 5 minutes there was another error message and the respirator no longer ventilated the patient.The patient then was manually ventilated and taken straight back to the intensive care unit.The patient had to be resuscitated.No additional injury was reported as a result of the situation.

Manufacturer Narrative

The investigation was started; results will be provided in a follow up-report.

Event Description

It was reported that during a transport of an intubated-ventilated patient at approximately 10:00 a.M., a low battery message from the ventilator occurred after approximately 10 minutes.The device was then reconnected to the power supply.After another 5 minutes there was another error message and the respirator no longer ventilated the patient.The patient then was manually ventilated and taken straight back to the intensive care unit.The patient had to be resuscitated.No additional injury was reported as a result of the situation.

Manufacturer Narrative

The logbook of the affected evita v600 with serial number (b)(6), photos, service report and e-mail correspondence were available for the investigation.Information on the circuit system and accessories used, the use of a closed suction system without expiration of the suction maneuver, and compliance with the requirements for electromagnetic compatibility according to the instructions for use in the patient's room and ct were not provided.Since the patient required resuscitation in the temporal context, further information was requested regarding the patient's health status after the reported event.This revealed that the patient made a complete recovery shortly after the event.Based on the results of the investigation on site and with the manufacturer, no malfunction of the internal battery or its performance could be identified.The ventilator was disconnected from ac power at 9:29 a.M.System time on the reported day of the event, according to log analysis.The ventilator issued a "low battery" alarm after 23 minutes of battery operation, which corresponded to battery performance (internal nimh battery) within specifications.At 9:54 a.M., the user reconnected to the line power supply.Contrary to what was reported, the device did not fail during battery operation.During this time, or in close temporal proximity, the alarm message "deconnection detected" was repeatedly issued and automatically reset a few seconds later in each case, after reconnection was detected.The software function "anti-air-shower" was activated on the ventilator by the user, whereby the flow was automatically reduced in the event of a detected disconnection until the detected reconnection.This specified device behavior is described in the user manual, but may have been misinterpreted by the user as a stop of ventilation.After mains power was restored, other ventilation-related alarms followed, e.G., "minute volume low," "airway pressure low," "no inspiratory flow detected," and "pressure limited," which were more likely due to the application or patient situation and did not represent a technical malfunction.A few minutes later, the user briefly switched to standby, then back to ventilation, disconnected the device from the mains power supply again, and finally ended therapy with the device at 10:01.For safety, the ventilator's software analyzes and verifies correct device function.If the performance of the device is limited by a functional or application fault, the user is alerted to the condition by appropriate acoustic alarms as well as a visual message in the display of the control unit.The alarm is triggered according to the alarm limits set on the device.In the event of a mains power failure or during transport, the ventilator is powered by the internal nimh battery to continue operation.Switchover to battery supply is indicated by an alarm.The specified battery runtime with a new and fully charged internal nimh battery during normal ventilation (without gs500) is approx.30 minutes.Depending on the battery capacity and battery voltage, additional alarm messages "battery low" and "battery discharged" are displayed as the battery life progresses.In the event of a complete power failure, the safety valve automatically opens against the environment, thus allowing the patient to breathe spontaneously.The ventilator's auxiliary audible alarm is immediately activated to alert the user to the equipment failure.This alarm is powered from an independent power source and lasts for at least 2 minutes.The dräger service technician has subsequently checked the device for correct device function according to manufacturer's specifications.Based on the results of the investigation in the field and in the logbook analysis, no deviation from the specified device function or device failure was detected.The results of this complaint investigation did not reveal any new or additional risks that have not yet been addressed in the ventilator risk management file.The number of similar cases due to the same cause is within the expected range of the respective risk assessment and is therefore accepted.

• Brand Name: EVITA V600
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 13839311
• MDR Text Key: 287528857
• Report Number: 9611500-2022-00077
• Device Sequence Number: 1
• Product Code: QOV
• Combination Product (y/n): N
• PMA/PMN Number: EUA 200143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

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 Catalogue Number: 8422300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention