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

Catalog Number 8603800

Device Problems No Flow (2991); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/30/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.We will provide results within a separate follow-up-report.

Event Description

It was reported that: " during induction with mask, o2 and air were given to the patient when the device stopped working.The o2 safety was locked.On the display there was a big exclamation point.On the display was shown the self test screen with the request to test ventilator valves.The test previously run before the operation ended with a fully operative device results.The keyboard of the device didn't work.Also pushing on o2 flush button didn't work".There was no injury reported.

Manufacturer Narrative

After the event, the device was tested by a drager service technician without any finding.The electronic log file was downloaded and made available for further analysis.A first review revealed that this file only contained the device related entries but no user interactions, such as settings, readings of gas concentration, pressure and volume or alarms.Hence it was not possible to reconstruct the reported event and determine the root cause.The device related section of the log which would provide information regarding error situations did not contain any information indicating a device failure.Neither for the reported date and time of event, nor for the entire rest of the covered period of time.Finally the reported event could not be reproduced.The on-site-test has not revealed a device failure and neither did the analysis of the log.Even if the device is completely powered down it still provides the possibility to carry out manual ventilation.In this case an adequate o2 safety flow has to be set using the o2 safety flow valve.The user may also apply agent as long as a functional and filled vaporizer is connected to the device.With an adequate setting of the apl valve the patient can be manually ventilated using the integrated breathing system.

Event Description

Please refer to the initial report.

• 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: 8033144
• MDR Text Key: 126181061
• Report Number: 9611500-2018-00350
• 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
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8603800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other