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

Catalog Number 8422300

Device Problems Circuit Failure (1089); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 09/04/2021

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 was found loudly alarming without ventilation function.There were no patient health consequences reported.

Manufacturer Narrative

The affected device was examined on site by dräger service and the log file as well as the circuit board pba m48.3 were provided to the manufacturer for further investigation.Based on the investigation the reported event could be confirmed; we thereby assume that the event occurred on (b)(6) 2021 at around 21:01 system time, as the log file recording stopped unexpectedly afterwards.Contrary to what was reported, the log file did not contain any entries with the system time stamp of (b)(6) 2021.The hardware analysis of the replaced circuit board pba m48.3 showed that due to a short circuit of the ceramic capacitor, the fuse had tripped as intended and thus interrupted the voltage supply of the circuit board.As a result, there was a complete loss of function of the pba m48.3 circuit board and the central control, ventilation and display functions of the device.The cause of the short circuit of the ceramic capacitor is not known.Replacing the circuit board pba m48.3 remedied the issue.In the event of a complete loss of ventilator function, the safety valve automatically opens against ambient, allowing the patient to breathe spontaneously.The auxiliary audible alarm is activated to alert the user of the failure.This alarm is supplied from an independent power source and lasts for at least 2 minutes.According to the description of the event, the auxiliary acoustic alarm was generated as specified.In terms of the product family evita v600/v800 und babylog vn600/vn800 there are no other complaints known with this specific component fault pattern.It is therefore assumed that there was a single component fault.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 was found loudly alarming without ventilation function.There were no patient health consequences reported.

• Brand Name: EVITA V600
• 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
• MDR Report Key: 12511585
• MDR Text Key: 273815968
• Report Number: 9611500-2021-00394
• Device Sequence Number: 1
• Product Code: QOV
• 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
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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