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

Catalog Number 8422300

Device Problems Failure to Deliver (2338); Complete Loss of Power (4015); Unexpected Shutdown (4019)

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

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The device was reported to have failed during ventilation and had a black screen.No patient injury was reported.

Manufacturer Narrative

The affected device was tested by dräger service and the logbook was saved for further analysis.The reported event could be confirmed on the basis of the logbook.On august 04, 2022 at 14:25 system time, data recording stopped unexpectedly during ventilation in spn-cpap/vs mode.There are no further entries in the logbook and on august 5th.During the on-site analysis, the device could not be started initially.In the device test, the circuit board pba m48.3 was identified as the cause of the malfunction.The device could be repaired by replacing the pba including the usd cards.In case of a complete loss of function of the ventilator the ventilation stops, and the safety valve opens automatically to the ambient allowing the patient for spontaneous breathing.The screen turns black and 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.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

The device was reported to have failed during ventilation and had a black screen.No patient injury was 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: 15282013
• MDR Text Key: 303344239
• Report Number: 9611500-2022-00215
• 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: 10/26/2022

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/24/2022
• Supplement Dates Manufacturer Received: 09/19/2022
• Supplement Dates FDA Received: 10/26/2022
• 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