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

Catalog Number 8411740

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2021

Event Type  malfunction  

Manufacturer Narrative

The log file of the affected device was available for the investigation.Based on the logbook entries, it was confirmed that the device detected a technical error on (b)(6) 2021 at 8:43 p.M.In response, warmstarts were performed until the device was switched off by the user at 8:45 p.M.The recorded error code indicates a deviation on the pcb pneumatic controller.The device can be repaired by replacing the affected pcb.The reported noise is due to the breathing system opening during a warmstart.The perceived smell is due to the overheated component on the circuit board.The use of ul-listed components minimizes a potential fire hazard.The device reacted as specified for this malfunction by initiating a warmstart in an attempt to solve the issue.During a warmstart the screen is switched to dark, an audible alarm is generated, and an emergency-breathing valve opens to allow for spontaneous breathing.In this case, the electronics problem could not be resolved by a warmstart.If a warmstart is unsuccessful, the audible alarm remains activated and the emergency breathing valve remains open.In this case, the instructions for use state that ventilation of the patient must be started immediately with an independent ventilation device.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 the evita suddenly switched itself off while ventilating a patient.A plop sound was heard, and a charred smell developed.There was no deterioration in patient health.

• Brand Name: EVITA 4
• 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: 11313409
• MDR Text Key: 231356796
• Report Number: 9611500-2021-00057
• 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: company representative,user f
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8411740
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2001
• 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