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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during surgery a stop of the anesthesia ventilator was seen by the anesthetist after induction and intubation.No injury reported.

Event Description

Please refer to initial mfr.Report # 9611500-2019-00420.

Manufacturer Narrative

The local service organization has inspected the device on-site, could confirm the reported problem and trace it back to a malfunction of the lower diaphragm of the piston ventilator.The diaphragm was replaced, the device has been tested to confirm readiness for operation and was put back in use.The log file sequence covering the period in question has been evaluated by the manufacturer.The findings confirm the expertise of the service engineer: the device was in use for approx.Half an hour before the supervisor function detected a vacuum pressure out of range.This vacuum pressure is needed to keep the piston diaphragm is place to avoid wrinkling during piston movement.The device is designed to shut down automatic ventilation to prevent from serious damages to the ventilator unit.The user is alerted to the shutdown by means of a corresponding alarm.Manual ventilation as well as the monitoring functions remain available to the full extent.The piston diaphragm is part of the 3 years maintenance kit because the material is exposed to deterioration and mechanical stress.It is not known when the last replacement of the diaphragm was performed with the particular device.The number of similar incidents is low in comparison to the installed base which is an indication that the exchange interval is appropriate.

• 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: 9443673
• MDR Text Key: 186762949
• Report Number: 9611500-2019-00420
• 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: 01/14/2020

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?: Yes
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1