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 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the device posted a gas mixer failure alarm during use.The initial analysis of the electronic log file revealed that also ventilation was interrupted, as well.

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 automatic ventilation and posted corresponding alarms.Monitoring and manual ventilation remain possible in this state.To continue with the particular surgery the user has established the emergency gas supply manually as explained in the ifu; no patient consequences have occurred.The device was used for 17 years now - the user facility has decided not to repair it; it has been taken out of service.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.The number of similar cases, related to the same phenomenon, is within the expected range of the respective risk assessment and thus accepted.The field failure rate is subject to permanent monitoring by the responsible product quality board and is rated as acceptable.

Event Description

It was reported that the device posted a gas mixer failure alarm during use.The initial analysis of the electronic log file revealed that also ventilation was interrupted, as well.

• 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: 15247867
• MDR Text Key: 298121229
• Report Number: 9611500-2022-00209
• 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
• Report Date: 09/27/2022

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?: Yes
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2005
• 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