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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2022

Event Type  malfunction  

Event Description

It was reported that during elective orthopaedic surgery, sudden failure of anaesthetic machine occured.Unable to oxygenate/ventilate/modify machine interface in any way therefore transferred immediately to anaesthetic room.Patient was stable throughout.

Manufacturer Narrative

The investigation was just startet.The result will be forwarded in a follow-up report.

Event Description

It was reported that during elective orthopaedic surgery, sudden failure of anaesthetic machine occured.Unable to oxygenate/ventilate/modify machine interface in any way therefore transferred immediately to anaesthetic room.Patient was stable throughout.

Manufacturer Narrative

The replaced pcb mobi was available for investigaiton.During functional tests a dräger, the reported problem could be reproduced.A failure of the coma (communication master) processor onboard this pcb was the root cause for the reported event.It was found that the coma-processor performed sporadic restarts.These restarts prevented from communication with the other components of the device and lfinally resulted in the reported error message "internal system fault! device cannot be used.Notify dräger service".All alarms, possible causes and remedies are described in the instructions for use.Replacement of the pvb mobi has fixed the problem.The number of similar cases 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 ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 15550001
• MDR Text Key: 301251892
• Report Number: 9611500-2022-00266
• 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
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2005
• 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