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

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2018

Event Type  malfunction  

Manufacturer Narrative

The device was examined by a draeger field service engineer.It could be revealed that the ceramic disc of the inspiratory valve was chipped.Due to the missing fragment and the resulting sharp contour the valve disc was jammed inside the cage.The inspiratory path thus remained open during inspiration; a sufficient ventilation was not possible anymore.From the readings and curves on the display as well as from the alarms the user was able to derive that the applied tidal volumes were significantly below the settings.A clear cause for the breaking of the valve could not be established.It is however seen unlikely that the disc can get damaged during its operational movement.It would be rather associated to inadequate reprocessing or false reassembly after that.Checking of the valves is part of the manual checklist to be performed prior to each use; for that purpose the cover of the breathing system is made from transparent material that the user can check if all valve discs are in place and free of damages.The particular valve disc had been replaced in follow-up of the event; the device passed all tests and is back in use.

Event Description

It was reported that suddenly during the procedure automatic ventilation became inefficient/impossible.The users bridged the time in manual ventilation until a back-up device was available.No consequences to the patient have reportedly occurred.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 451882268
• MDR Report Key: 8140910
• MDR Text Key: 130051442
• Report Number: 9611500-2018-00389
• 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
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2007
• 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