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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation was just startt.The results will be provided in a follow-up report.

Event Description

It was reported that the device failed during operation with ventilator failure, respiratory temperature too high.

Event Description

It was reported that the device failed during operation with ventilator failure, respiratory temperature too high.

Manufacturer Narrative

For the investigation the information provided and the logbook were analyzed.The described ventilator failure could be reconstructed on the base of the logbook records.At the time of the described event, the logbook shows a voltage failure in the vgc module (ventilation and gas controller).As a result, the analogue signal measurements, which includes the sensors that monitor airway pressure and breathing gas temperature, failed.Without these measurements the protection against potentially hazardous output is compromised and thus, the device is designed to force a shut-down of automatic ventilation and post a corresponding alarm.The root cause for this was found to be a mechanical shearing of a coil.It is assumed that the problem occurred during service that took place immediately before and was initially unnoticed.This is assessed to be a single case.

• Brand Name: PRIMUS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 12082121
• MDR Text Key: 261699708
• Report Number: 9611500-2021-00278
• 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: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• 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
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1