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 Insufficient Information (4580)

Event Date 07/14/2021

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 a ventilator and mixer failure occurred during use.No injury reported.

Manufacturer Narrative

The log file analysis revealed that during the case in question the device detected an internal communication error onboard a pcb that controls the communication between user interface, gas mixer and ventilator.The workstation initiated an emergency shutdown of the ventilator and gas mixer, resulting in a change to monitoring mode while corresponding alarms were posted.Monitoring and manual ventilation remain possible in this state.The general issue is known from earlier occurrences of the same phenomenon.Intensive evaluation of the provided information and testing of concerned materials did not result in any finding.The fact that the involved pcb is used in another functional unit of the entire device without showing similar symptoms makes a design problem rather unlikely.A reasonable explanation would be emc disturbances beyond the immunity barriers of the workstation which is compliant to iec 60601-1-2.Therefore it is recommended that the conditions at the user facility should be checked to prevent from emc disturbance.The field failure rate of the affected pcb is accepted.

Event Description

It was reported that a ventilator and mixer failure occurred during use.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.

Event Description

It was reported that a ventilator and mixer failure occurred during use.No injury reported.

• 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: 12311886
• MDR Text Key: 267838519
• Report Number: 9611500-2021-00341
• 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: Biomedical Engineer
• 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: 08/12/2021
• 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: 08/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2003
• 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