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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Intermittent Communication Failure (4038)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has been started, results will be provided with the follow-up report.

Event Description

It was reported that there was a ventilator failure during use.There was no patient injury reported.

Event Description

It was reported that there was a ventilator failure during use.There was no patient injury reported.

Manufacturer Narrative

The investigation was carried out based on the available information and logfile analysis.Unfortunately, the received logfiles do not cover the date of event because the technician performed a configuration reset before taking the log which leads to the device being set to default and deleting all information stored in the logfile.Based on the information that both, ventilator and gas mixer, were affected, most likely, a sporadic malfunction of a cpu board which controls the device-internal communication between user interface and vgc (ventilation and gas controller) was the root cause of the reported failure.In case of such failure, the device reacts according to its safety concept, performs an emergency shutdown of the affected components and automatically switches to monitoring mode while alarming the user to this condition by means of a corresponding alarm.Manual ventilation with emergency oxygen dosage remains possible including the application of anesthetic gas as well.The monitoring functionality remains unaffected.Similar cases are known ¿ however, the exact failure mechanism could not be determined during in-depth analysis.It was only possible to narrow down the root cause to the respective pcb.The fact that the identical type of board is used in the workstation twice and does not exhibit malfunctions in the second application periphery makes a general design issue rather unlikely.A reasonable explanation would be electrostatic discharge of the user during interaction with the device or any other kind of electromagnetic disturbance that exceeds the immunity barriers of the device.The primus was developed in compliance to the requirements of iec 60601-1-2.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• 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: 11929042
• MDR Text Key: 257704769
• Report Number: 9611500-2021-00238
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• 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?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1