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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device generated a check vent.Assembly alarm during use, indicating a relevant leak.There was no patient injury reported.

Manufacturer Narrative

The device was subject to a long-term test run in the manufacturer's lab.The reported behavior could be duplicated - the device detected sporadic deviations of more than 25% between the tidal volume applied by the ventilator and the volume readings of the inspiratory flow measurement.Corresponding alarms ("check vent assembly") were posted as reported by the user.The issue could be narrowed down to a chipped ceramic disc in one of the valves inside the compact breathing system (cosy).The sharp contour edge of the missing fragment was sporadically jamming inside the cage that keeps the valve disc in place.This jamming resulted intermittently in loss of volume and pressure during automatic ventilation because the valve did sometimes not close properly when intended.It can be concluded that the device responded as designed to the restriction of automatic ventilation; corresponding alarms were posted.As the valve is permanently open during manual ventilation the particular deviation does not come into effect in this mode.The root cause for the damage of the ceramic disc could not be determined during the course of investigation.The cosy has to be partly disassembled for reprocessing - hence, disassembly, cleaning/disinfection process and reassembly would be imaginable steps where the crack might have occurred.Post market surveillance data reasonably suggests the suitability of the design since there is no comparable case of a medical device vigilance report known.

Event Description

Please refer to initial mfr.Report #9611500-2018-00218.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• Manufacturer (Section G): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; luebeck, 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 7649504
• MDR Text Key: 113009714
• Report Number: 9611500-2018-00218
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2004
• 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