MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA PRIMUS INFINITY EMPOWERED; ANESTHESIA UNITS

Catalog Number 8607500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that a device failure occurred when switching from ippv to man/spont.The patient was subsequently ventilated via ambu bag.No injury reported.

Manufacturer Narrative

The ventilator failure described by the user could be reconstructed by means of the logfile analysis.No indications for a device malfunction were found.Also during on-site checking in follow-up to the event, no indications for a device malfunction leading to the reported symptom were found.It was further confirmed by the user that the patient coughed at the time of event.Based on the logfile analysis, it could be reconstructed that the autonomous safety shutdown of the ventilator was triggered by a faulty motor position as a result of frequently changing positive and negative pressure peaks ¿ due to the patient coughing against the ventilator.At the time in question, pressure control ventilation was used; in general, it is recommended to switch on the synchronization for spontaneously breathing patients (e.G.Pressure mode with activated trigger) or use synchronized ventilation mode (e.G.Pressure support).The device behaved as specified with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.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 a device failure occurred when switching from ippv to man/spont.The patient was subsequently ventilated via ambu bag.No injury reported.

• Brand Name: PRIMUS INFINITY EMPOWERED
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11377446
• MDR Text Key: 233449395
• Report Number: 9611500-2021-00084
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042607
• 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: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607500
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.