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

Catalog Number 8607500

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

It was reported that the ventilator failed during use.There was no patient injury reported.

Manufacturer Narrative

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

Event Description

It was reported that the ventilator failed during use.There was no patient injury reported.

Manufacturer Narrative

Based on the available log file, the reported case could be reconstructed.It was found that during the case in question, a failure of the inspiratory pressure sensor of the vgc (ventilation and gas controller) was detected by the device.In consequence, the ventilator initiated an autonomous shutdown while changing mode to man/spont accompanied by the corresponding "ventilator fail" alarm as specified.In this case, manual ventilation as well as monitoring function remains unaffected.Dräger finally concludes that the device reacted as specified upon a sporadic failure of the inspiratory pressure sensor.On-site, in follow-up of the event, the dispatched fse replaced the affected pressure sensor as a precautionary measure.The device was successfully tested afterwards and was returned to use without further problems reported.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: PRIMUS INFINITY EMPOWERED
• Type of Device: ANESTHESIA UNITS
• 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: 12777704
• MDR Text Key: 282276670
• Report Number: 9611500-2021-00456
• 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: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2008
• 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