MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA 4; VENTILATORS, INTENSIVE CARE

Catalog Number 8413454

Device Problem Increase in Pressure (1491)

Patient Problem Pneumothorax (2012)

Event Date 02/24/2024

Event Type  malfunction  

Event Description

It was reported that the evita 4 ventilator displayed error messages in the pressure measurement and peep (measured value 16mbar) high.After the peep high alarm was triggered, the peep immediately dropped to the set value and increased again per ventilation stroke.The alarm behavior corresponds to the increment defined by the manufacturer for the peep high alarm of 8mbar.The patient became short of breath (dyspnoea) due to the increased peep of up to 16 mbar.Due to the dyspnea and forced inspiration of the patient, a pneumothorax occurred.The device has alarmed.At the present time, we can not exclude a device malfunction or user error that led to the reported event.

Manufacturer Narrative

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

• Brand Name: EVITA 4
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18950061
• MDR Text Key: 338248764
• Report Number: 9611500-2024-00122
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K980642
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8413454
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2002
• 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