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

Catalog Number 8603800

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Sense (1559); Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started, the result will be forwarded in a follow-up report.

Event Description

It was reported that approximately after 2 hours of anesthesia ventilator alarmed ' ventilation malfunction', only hand ventilation available.Ventilator stopped but hand ventilation worked.Staff was not able to turn on normal ventilator operation.Patient was disconnected from ventilator and hand ventilated.The ventilator was shut down and restarted.Normal testing done without errors.Patent was reconnected to primus and it worked normally to the end of surgery.No injury reported.

Manufacturer Narrative

For the investigation the logfile was analysed.A too high negative vacuum pressure was detected by the device during the case in question, indicating a faulty vacuum pressure sensor (pu) on the pcb vgc analog.The device alarmed optical and acoustical with "ventilator fail".In consequence the ventilator initiated an autonomous shutdown and the ventilation mode was automatically changed to man/spont as specified.The unit was powered off and back on.As the device passed the following post and therapy was continued without problems, it was concluded that the reported symptom was caused by a sporadic outage of the vacuum pressure sensor (pu).The device behaved as specified upon a sporadic failure of a single component and generated the adequate alarms.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 approximately after 2 hours of anesthesia ventilator alarmed ventilation malfunction', only hand ventilation available.Ventilator stopped but hand ventilation worked.Staff was not able to turn on normal ventilator operation.Patient was disconnected from ventilator and hand ventilated.The ventilator was shut down and restarted.Normal testing done without errors.Patent was reconnected to primus and it worked normally to the end of surgery.No injury reported.

• 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: 13505101
• MDR Text Key: 288098252
• Report Number: 9611500-2022-00042
• 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: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2010
• 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