MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA EVITA V800; VENTILATORS, INTENSIVE CARE

Catalog Number 8422500

Device Problems Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)

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

Event Date 03/14/2023

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 user performed an aspiration using closed system and the device alarmed for negative pressure.It was reported that this event, no ventilation was remaining even when the device was witch to standby mode and ventilation mode.

Event Description

It was reported that the user performed an aspiration using closed system and the device alarmed for "negative pressure".It was reported that this event, no ventilation was remaining even when the device was witch to standby mode and ventilation mode.

Manufacturer Narrative

The log file was analysed for investigation.Based on the log file analysis the reported device behaviour could be confirmed.As per log file the device posted an airway pressure negative alarm caused by a performed closed suction.As specified gas delivery stopped and the safety valve opened to ambient to allow spontaneous breathing.However, the log file analysis revealed that the airway pressure negative alarm was not withdrawn after the suction process.The log file entries indicated a deviation in the calibration of the pressure sensors.Therefore, the pba pvt-monitoring (pressure, flow and temperature) and the calibration unit (for the calibration of the pressure sensors) were exchanged and send in for investigation.The pba pvt-monitoring was analysed and tested without any deviation.The examination of the calibration unit revealed a delayed switching behaviour of one valve necessary for calibration the corresponding pressure sensor to ambient pressure.Therefore, the sensor was not correctly calibrated under ambient pressure and measured a pressure less than -1 mbar in normal condition.Since the measured pressure values must be above -1 mbar to cancel the alarm condition, the airway pressure negative alarm was not withdrawn.In the present case the calibration unit already has been replaced.In the present case no patient harm was reported.The number of similar cases, related to the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.

• Brand Name: EVITA V800
• 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: 16681098
• MDR Text Key: 312682860
• Report Number: 9611500-2023-00129
• Device Sequence Number: 1
• Product Code: QOV
• UDI-Device Identifier: 04048675542148
• UDI-Public: (01)04048675542148(11)210406(93)8422500-04
• 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: 05/24/2023

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: 8422500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 05/23/2021
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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