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

Catalog Number 8603800

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 05/04/2022

Event Type  malfunction  

Event Description

It was reported that a ventilator failure occurred during use.As per report, this did not lead to any consequences for the patient.

Manufacturer Narrative

The reported event can be confirmed upon log file evaluation - the recorded error codes indicate that the supervisor function of the software initiated a shutdown of automatic ventilation because the ventilator piston has reached the end position at a time it should not.The piston hub is an equivalent to the volume the ventilator applies and, to protect from potentially hazardous output and/or from serious damages to the ventilator unit the device is designed to shut down automatic ventilation and to post a corresponding alarm; manual ventilation is further available as well as the monitoring functions of the device are.The triggering condition for the error is either to be associated with the motor itself or with the position detection system.The involved device is almost 12 years old, it cannot be excluded that wear and tear of the motor has resulted in speed fluctuations and thus, to a divergence between calculated and measured piston position.On the other hand, it would be imaginable that dust particles on the encoder disc may have disturbed the optical position detection.The local s&s organization will be advised to replace the entire ventilator unit including position detection system to put back the device into fully operable condition.Dräger finally concludes that the device behaved as designed for this specific error condition; the issue does not incorporate a previously unidentified or falsely assessed risk.

• Brand Name: PRIMUS
• 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: 14786240
• MDR Text Key: 297604196
• Report Number: 9611500-2022-00156
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2010
• 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