MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA INFINITY ACS - EVITA V300; VENTILATORS, INTENSIVE CARE

Catalog Number 8420440

Device Problems Failure to Deliver (2338); Inaccurate Delivery (2339); No Pressure (2994)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation was started but is not yet concluded.Investigation results will be provided in a follow-up report.

Event Description

It was reported that ventilation suddenly failed during operation.The device alarmed "low minute volume," but no failure of the gas supply.The patient's oxygen saturation decreased, but no serious consequences have been reported.

Event Description

It was reported that ventilation suddenly failed during operation.The device alarmed "low minute volume", but no failure of the gas supply.The patient's oxygen saturation decreased, but no serious consequences have been reported.

Manufacturer Narrative

The affected evita v300 was available for a manufacturer's investigation at the repair workshop.A malfunction of the ventilator could be confirmed by a hardware analysis and a logbook analysis.The log entries indicate a deviating gas delivery, but no complete failure of the gas delivery could be confirmed.It can be verified that several ventilation-related alarm messages such as "minute volume low" were issued.During the examination of the device in the repair workshop in lübeck the deviation could be limited to a faulty circuit board of the gas and dosing module and circuit board pv monitoring.In the reported case, the device reacted as specified and issued appropriate alarm messages to alert the user to the deviation as corresponding alarm limits were met with regard to ventilation-relevant parameters.After a repair exchange of the affected circuit boards, the device showed no more deviation.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: INFINITY ACS - EVITA V300
• Type of Device: VENTILATORS, INTENSIVE CARE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 10458666
• MDR Text Key: 205579211
• Report Number: 9611500-2020-00306
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

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: 8420440
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/27/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1