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

Device Problems Premature Discharge of Battery (1057); Failure to Deliver (2338); Complete Loss of Power (4015)

Patient Problem Insufficient Information (4580)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

The log file of the affected device was made available for the investigation.Based on the log file analysis it could be confirmed that the device detected an inconsistency in the state of data stored in a memory chip and alarmed accordingly.The ventilation was not affected by this issue and continued as set according to the log file.Based on the log file analysis, it could furthermore be verified that 14 minutes afterwards the external battery was activated.One minute after activation of the external battery the device shut down due to depleted/worn batteries.If the internal and external batteries are depleted, the device shuts down with audible power failure alarm in case the device is disconnected from the mains.The power failure alarm lasts until the independent power source is depleted; a minimum of 2 minutes is ensured by design.In this case of power failure, the emergency-breathing valve opens in order to allow spontaneous breathing of the patient.The user¿s report included only the aspect of the alarm for data inconsistency and indicated that the use of the device was discontinued intentionally.Therefore, it can be assumed that the patient was transferred to another device within the next 14 minutes already and that the initially used ventilator was disconnected from mains.Following from that the shut-down due to depleted batteries was most likely happening at a time when the patient was already disconnected.However, the available information allows no reliable conclusion in regard to this aspect and, the event is reported in abundance of caution.The device reacted as specified to the detected deviations and generated corresponding alarms.The log file indicates that the external and internal batteries were out of specification i.E.The shutdown was performed due to loss of power.The batteries are intended to ensure a continued device operation in cases of mains power losses and thus, incorporate an important fail-safe mechanism.These are wearing parts and shall be replaced every 2 years during maintenance.Replacing the batteries was recommended as a preventive measure.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that while using this device for a covid19 patient, a device failure occurred and the use of the device was discontinued.There were no patient health consequences reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.Not returned to manufacturer.

Event Description

It was reported that while using this device for a covid19 patient, a device failure occurred and the use of the device was discontinued.There were no patient health consequences reported.

• Brand Name: EVITA XL
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12340684
• MDR Text Key: 268565879
• Report Number: 9611500-2021-00352
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K083050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1