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

Catalog Number 8603800

Device Problem No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

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 a reinstall ventilator alarm was posted during use.Based on the available information it cannot be excluded that the airway pressure dropped to ambient.There was no injury reported.

Manufacturer Narrative

The dispatched service engineer has checked the log file and - based on findings - has replaced the vacuum pump and a dedicated valve.The machine passed all consecutive tests and is back in use.Log file review performed by the manufacturer confirms the initial expertise.Right from the beginning of automatic ventilation during the concerned procedure the device measured an insufficient vacuum pressure inside the ventilator piston.This pressure is required to keep he piston diaphragm in place and to avoid wrinkling.Since dislocation of the diaphragm in case of pressure problems can cause severe damages to the ventilator unit during piston movement, the device is designed to cut-off automatic ventilation if the vacuum pressure goes below a certain threshold and to alert the user to this condition by means of a corresponding alarm.Manual ventilation with the built-in breathing bag as well as the monitoring functions remain available.In the particular case the log indeed indicates that the loss of vacuum pressure was in a range where ventilation was still available; only the initial step of the safety concept was activated - the alarm indicating a low vacuum pressure.Dräger finally concludes that the device detected a deviation and responded to it as per definitions of the safety concept.The log indicates that the grade of deviation was during the particular ventilation episode still in a range where automatic ventilation could be held upright.The malfunction of a single pneumatic component after 16 years of use can be considered acceptable.

Event Description

Please refer to initial mfr.Report #9611500-2019-00425.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9443667
• MDR Text Key: 175271891
• Report Number: 9611500-2019-00425
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• 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
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1