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

Catalog Number 8413940

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The affected device was examined onsite by biomed and a pneumatic controller board was identified which was not plugged in correctly.Furthermore, it was confirmed that the device had generated a device error.The investigation at the manufacturer¿s site was based on the provided description of event as only available information.Considering the device error, it could be verified that the device very like performed a warm start.In the event of a warm start, audible alarms and visual messages are generated in order to alert the user of this situation.The device briefly powers off and then back on.A single successful warm start lasts approximately 8 seconds.The emergency-breathing valve would open allowing for spontaneous breathing; however, manual ventilation with an alternate device may be considered necessary.Reportedly re-plugging in the pneumatic controller board correctly remedied the issue.A one-day test run was performed as well without further deviations.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 during use that the ventilator restarted.There was no patient injury reported.

• 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
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11595035
• MDR Text Key: 244376824
• Report Number: 9611500-2021-00139
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/18/2021,03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8413940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Report to Manufacturer: 03/18/2021
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2006
• 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