MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V300; VENTILATORS, INTENSIVE CARE

Catalog Number 8420400

Device Problems No Display/Image (1183); Device Difficult to Program or Calibrate (1496)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that the screen went dark while the patient was being ventilated.Ventilation was continued.The device was disconnected from the patient and made available for repair.There were no patient health consequences reported.

Manufacturer Narrative

Contrary to the information as provided initially, the affected device was an infinity acs workstation cc (evita v500) with a c500 cockpit.The affected c500 cockpit was returned to the manufacturer's repair workshop for examination.The reported display malfunction could be reproduced.The ccfl tubes (fluorescent tubes) of the cockpit were faulty and caused an impaired display illumination.Due to the limited visibility of the display content, the operability of the ventilator by the user may be impaired.The display was completely replaced.Ventilation is not affected by a malfunction of the cockpit display and continues as set.Safety-relevant parameters such as fio2, minute volume or airway pressure are shown on the secondary oled display of the ventilator and the user can monitor the ongoing ventilation.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 screen went dark while the patient was being ventilated.Ventilation was continued.The device was disconnected from the patient and made available for repair.There were no patient health consequences reported.

• Brand Name: EVITA V300
• 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: 18985054
• MDR Text Key: 338753328
• Report Number: 9611500-2024-00131
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 04048675389354
• UDI-Public: (01)04048675389354(11)191015(17)200304(93)8420400-11
• Combination Product (y/n): N
• PMA/PMN Number: K093633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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 Catalogue Number: 8420400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2019
• 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
• Treatment: NA.; NA.