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

Catalog Number 8422500

Device Problems Use of Device Problem (1670); Failure to Deliver (2338); No Apparent Adverse Event (3189)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Respiratory Arrest (4461)

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was returned to intensive care after a surgery and reconnected to the device at 13:28 (1.28 p.M.).At 13:57 (1.57 p.M.) the patient suffered a hypoxic cardiorespiratory arrest.

Manufacturer Narrative

The investigation was based on the reported event, further email correspondences and logfile analysis of the evita v800 with the serial no.(b)(6) at the manufacturer site.In the following correspondence it could be clarified that the patient was in an or room between 11:27 bis 13:28 pm which was also analyzed via the logfile documentation.Since the time of the affected device was not adjusted, a time shift of +1h was documented here.After returning to the its, the patient was reconnected to the device at 1:28 p.M (device system time) and several settings were made, according to the log file.However, the device was not activated from standby.That did not happen until 2:55 pm, according to the log file.After that, several alarm messages concerning "airway pressure high" were posted around that time.At 7:08 pm the device was switched into standby mode.As per log file a system test was performed successful on november 19th.A device malfunction or a stop of the ventilation could not confirmed.A misinterpretation of the anti-air shower function, as initially reported, could not be confirmed.Obviously, the user was not aware about the ventilation was in standby mode.In case that the ventilation will not started by the user the device remains in standby mode.The patient would not ventilated.The text ¿standby patient not ventilated" would displayed on the screen.The results of the investigation did not reveal any new risks which are not covered by the product risk management file.

Event Description

It was reported that the patient was returned to intensive care after a surgery and reconnected to the device at 13:28 (1.28 p.M.).At 13:57 (1.57 p.M.) the patient suffered a hypoxic cardiorespiratory arrest.

• 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
• MDR Report Key: 12922536
• MDR Text Key: 281652363
• Report Number: 9611500-2021-00481
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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