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); Decrease in Pressure (1490); Failure to Deliver (2338)

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

Event Date 05/31/2022

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 suddenly turned off at about 2:30 a.M.On (b)(6), 2022.This caused a very high-pitched alarm to sound.The machine was set in bipap mode until that time.It was reported that the device could not be switched on afterwards.There was no patient harm.

Manufacturer Narrative

The affected device, evita v600, was examined onsite by dräger service and a faulty circuit board pba m48.3 was identified as root cause of the device malfunction.Die affected circuit board pba m48.3 was made available for further investigation at the manufacturer¿s site.The hardware analysis of the returned pba m48.3 circuit board revealed an overload at the input for the 5v voltage supply due to a short circuit of the ceramic capacitor c5.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 c5 could not be determined.Replacing the circuit board pba m48.3 remedied the issue, and the device was finally successfully tested according to the manufacturer's specifications.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.In the current event, the device reacted as specified on the complete loss of device function and generated the auxiliary acoustic alarm as specified.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 suddenly turned off at about 2:30 a.M.On may 31, 2022.This caused a very high-pitched alarm to sound.The machine was set in bipap mode until that time.It was reported that the device could not be switched on afterwards.There was no patient harm.

• 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: 14710739
• MDR Text Key: 297602764
• Report Number: 9611500-2022-00144
• Device Sequence Number: 1
• Product Code: QOV
• Combination Product (y/n): N
• PMA/PMN Number: EUA200143
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2020
• 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