MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS WORKSTATION CC; VENTILATORS, INTENSIVE CARE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Pressure (2994)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/28/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that during ventilation of a patient suffering from corona, the device emitted pulsating, clacking noises.All modes on the cockpit were greyed out and therefore no user input was possible.According to the user, the patient was not ventilated during this time and the saturation dropped to 48% within seconds.Only after changing the device could a saturation of almost 85% be reached again after several hours, after which the patient died.

Manufacturer Narrative

On (b)(6), a few days before the event, a comprehensive inspection of the unit was carried out according to the manufacturer's specifications as part of a 6-year maintenance.The investigation of the event has been carried out based on the description and the logbook provided.The analysis of the logbook revealed several pressure releases as a result of reaching the set maximum inspiratory ventilation pressure.These depressurisations correspond to the clacking sounds described.When excessive airway pressure occurs, the infinity acs workstation cc (evita v500) will relieve pressure to protect the patient from excessive airway pressures.In the first instance, the evita v500 opens the expiration valve to relieve the pressure.If this is not sufficient, the safety valve against the environment is opened in the second instance and a pneumatic reset is carried out.Reaching the maximum ventilation pressure may be due to the patient's condition or obstructions in the tubing system.In the present event, more than 60 pressure releases were initiated by the evita v500 between 19:55 and 19:57.Several alarms regarding "mv low" and "airway pressure high" were issued by the unit around the reported time.According to the logbook, several suction manoeuvres were performed between 22.02 and 28.02.On 26.02 and 27.02 several alarms were issued regarding "airway obstructed?".On the day of the event, the unit was operated by the user at 19:57 and the fio2 concentration was set from 90% to 100%.The entries showed that the alarms that occurred on the day of the event ("airway pressure high", "mv low") as well as the pressure relief as a result of reaching the maximum respiratory pressure had already occurred several times since 23.2 and 21.2 respectively.The logbook analysis does not indicate a device malfunction.The reported circumstance "all modes in the cockpit greyed out" could also not be confirmed on the basis of the logbook analysis.It can happen that control panels are greyed out if, for example, there is a communication problem between the display and the ventilation unit of the evita v500.The existence of a communication problem between the two components could not be confirmed based on the logbook analysis.However, the greying out of entire areas would not be possible even in the case of permanent pressure relief.This could be confirmed by means of a laboratory test on an independent device.The screenshots of the screen included in the logbook, however, show that the manoeuvres were greyed out after switching to standby mode and that the user tried to select a manoeuvre.An attempt by the user to change the ventilation modes while the patient was being ventilated could not be seen in the logbook.Overall, the described behaviour of the device could be reconstructed on the basis of the detailed logbook analysis.The evita v500 behaved as specified and issued appropriate alarms to inform the user of the situation.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 during ventilation of a patient suffering from corona, the device emitted pulsating, clacking noises.All modes on the cockpit were greyed out and therefore no user input was possible.According to the user, the patient was not ventilated during this time and the saturation dropped to 48% within seconds.Only after changing the device could a saturation of almost 85% be reached again after several hours, after which the patient died.

• Brand Name: INFINITY ACS WORKSTATION CC
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11454835
• MDR Text Key: 238931850
• Report Number: 9611500-2021-00103
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K093633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2009
• 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
• Patient Outcome(s): Death