MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V600; VENTILATORS, INTENSIVE CARE

Catalog Number 8422300

Device Problems Gas Output Problem (1266); Decrease in Pressure (1490); Reset Problem (3019); Intermittent Communication Failure (4038)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device has performed a shutdown during the ventilation.No patient consequences have been reported.

Manufacturer Narrative

The analysis of the available description of event revealed that the service technician found a faulty pba m48.3 circuit board onsite as the root cause in the reported event.The replacement of the affected part solved the problem.In case of a complete loss of function of the ventilator, the safety valve automatically opens to ambient allowing the patient for spontaneous breathing.The secondary acoustic alarm system (piezo speaker) of the ventilation unit will be activated in order to alert the user to the situation.This alarm is energized from an independent power source and will be last for at least 2 minutes.There was no patient injury reported.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 device has performed a shutdown during the ventilation.No patient consequences have been reported.

Event Description

It was reported that the device has performed a shutdown during the ventilation.No patient consequences have been reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.Not returned to manufacturer.

• Brand Name: EVITA V600
• 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: 11751542
• MDR Text Key: 250431386
• Report Number: 9611500-2021-00188
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• PMA/PMN Number: EUA 200143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2022

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: 8422300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 04/30/2021
• Supplement Dates Manufacturer Received: 06/25/2021; 06/25/2021
• Supplement Dates FDA Received: 07/01/2021; 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2020
• 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