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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

A dräger service engineer examined the device in follow-up of the event and could confirm the reported shut-down of automatic ventilation upon review of the log files.The issue could be traced back to the sensor which monitors the auxiliary vacuum pressure.The auxiliary vacuum pressure is needed to actuate the valves that control the ventilation and to keep the ventilator diaphragm in place during piston movement.If this vacuum pressure cannot be built-up anymore or - like in the particular case - can't be measured, the system reacts during use with a shutdown of automatic ventilation and generation of a corresponding alarm.This is readily apparent to the user who has then to continue patient support in manual ventilation, at least until availability of a replacement device.Monitoring functions and gas dosage remain unaffected.The device is back in use after replacement of the pcb which has the pressure sensor onboard.The field failure rate is inconspicuous and accepted.

Event Description

It was reported that the device alarmed during use for ventilator failure and shut down automatic ventilation.The users replaced the device;no patient consequences 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 (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11300224
• MDR Text Key: 232027337
• Report Number: 9611500-2021-00054
• 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
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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