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

Catalog Number 8603800

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that during ventilation the device alarmed "ventilator failure.Manual ventilation possible".No injury reported.

Event Description

It was reported that during ventilation the device alarmed "ventilator failure.Manual ventilation possible".No injury reported.

Manufacturer Narrative

The investigation was carried out based on evaluation of the electronic log file.A sporadic malfunction of a cpu board which controls the device-internal communication between user interface and vgc (ventilation and gas controller) was identified to be root cause of the reported failure.This leads to a shutdown of the ventilator and gas mixer.In this situation, the device automatically switches to monitoring mode while alarming the user to this condition by means of a corresponding alarm.For the actual case, the unit was on standby - a patient was not connected.As described in the ifu manual ventilation with emergency oxygen dosage remains possible including the application of anesthetic gas as well.Dräger finally concludes, that the device has reacted according to its safety concept and has performed an emergency shutdown of the affected components accompanied by the respective alarms.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.

Event Description

It was reported that during ventilation the device alarmed "ventilator failure.Manual ventilation possible".No injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

• Brand Name: PRIMUS
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 12133803
• MDR Text Key: 262887587
• Report Number: 9611500-2021-00295
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2007
• 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