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

Catalog Number 8419601

Device Problem Self-Activation or Keying (1557)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2019

Event Type  malfunction  

Manufacturer Narrative

The keypad of the display of the involved device was available for investigation at the manufacturer.The root cause for the reported switch to standby were conductive residues from the keypad manufacturing process between the conductive paths to the standby button.As a consequence the device assumed a continuously pressed standby button.If the button is detected as pressed for longer than 3 seconds without interruption, the evita xl switches to the "standby" mode and alarms visually and audible with the high priority warning " standby activated !!! ".This alarm remains active until the user confirms the alarm via the "alarm reset" screen key or the button ¿start / standby¿ is detected as pressed again.In standby mode, the patient can breathe spontaneously via the emergency breathing valve.Even with a continuously low resistance "start / standby" button, ventilation can be restarted by selecting "start" on the screen and pressing the rotary knob.This type of manufacturing problem has never be observed before therefore this is rated to be a single occurrence.The device alarmed as specified.After replacing the keypad the 9 year old device will be handed over to the customer again.

Event Description

It was reported that the ventilator was connected to a patient and after a short time, the ventilator entered standby mode by itself, the nurse was uncertain what has happened, but again the ventilator entered standby mode by itself.

• Brand Name: EVITA XL
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 8978499
• MDR Text Key: 174771611
• Report Number: 9611500-2019-00267
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8419601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2019
• Initial Date FDA Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2019
• 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