MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA 2 DURA; VENTILATORS, INTENSIVE CARE

Catalog Number 8413452

Device Problems Decrease in Pressure (1490); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/23/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the device posted "peep valve failure" while in use on patient.The user switched to another device because the device setting was not possible to change.The patient died after the user replaced the device.The user additionally reported that the patient condition was serious before the device was used on the patient.Currently it cannot be excluded that a device malfunction or handling problem contributed to the patient state.

Manufacturer Narrative

For the investigation the logfile and the provided information was analysed.The service engineer on site tested the device without deviation.According to the logfile the reported error message "peep valve inop" could be confirmed.It was found that on (b)(6) 2019 the device alarmed between 11:13 pm and 11:49 pm continously with the high priority alarm "peep valve inop".At the same time the high priority alarm "apnoe " was generated for several times.The alarm "peep valve inop" indicates that the measured peep is 5 mbar lower than the set value for 10 ventilation cycles.Possible root causes are a faulty internal peep valve or a leakage in the breathing system.The alarm "apnoe !!!" indicates that an insufficient inspiratory and expiratory breathing activity of the patient has been measured within the set tapnoea alarm limit time.No technical failures were found neither during the testing on site nor during logfile analysis.Testing of the peep valve showed no deviation and consequently it was not the root cause for the reported alarm.Therefore, we concluded that the device behaved according to specification and generated the adequate alarms in order to inform the user about the given situation.

Event Description

Please refer to the initial report.

• Brand Name: EVITA 2 DURA
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9422497
• MDR Text Key: 169407910
• Report Number: 9611500-2019-00415
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K970165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8413452
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death