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 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a ventilator failure during use.There was no patient injury reported.

Manufacturer Narrative

The ventilator failure could be reconstructed by means of the logfile analysis.No indications for a device malfunction were found.The autonomous safety shutdown of the ventilator was triggered by a significantly increased airway pressure peak.Typical reason for this is an existing lack of fresh gas in combination with spontaneous breathing efforts of the patient.However, in the course of investigation, the user denied that the patient did breathe spontaneously or that suction was used.Nevertheless, no indications for a technical device failure were found ¿ the replaced motor unit was tested in a lab device and no deviations from specification were found.A test run for several days was successfully completed without any findings.Thus, the exact root cause for the found instable pressure situation cannot be determined finally.It can be concluded that the device in question behaved as specified upon the detected pressure situation 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 phenomenon, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that there was a ventilator failure during use.There was no patient 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: 11116017
• MDR Text Key: 228946942
• Report Number: 9611500-2021-00001
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1