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 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.H3 other text : on-going.

Event Description

It was reported that after start of the operation the device posted a "gas delivery + ventilator fail" alarm.The procedure was continued with a back-up device.No injury reported.

Manufacturer Narrative

According to the log file the ventilator board repeatedly stopped its can/sa-bus communication, which interrupted the communication between user interface (mobi) and ventilator as well as the one to the gas mixer, as this communication including settings and status feedback is routed via the ventilator.Resulting from the loss of communication, ventilator and gas mixer initiated an emergency shutdown to monitoring mode while the mobi alarmed for gas + vent fail including the prompts mentioned above.It can be concluded that the reported event was caused by an internal communication problem of the ventilator¿s cpu board.Manual ventilation, using the device breathing bag while setting an adequate flow via the o2 flow control valve (incl.Agent) remained possible.Based on the fact, that the same pcb is also assembled in the gas mixer without showing this symptom, a general design failure can be excluded.It cannot be excluded that the reported phenomenon was triggered by electromagnetic radiation or electrostatic discharge of the user during interactions with the device.Apollo is designed, tested and certified to withstand emc/esd influence in conformance to the relevant standard (iec 60601-1-2).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 after start of the operation the device posted a "gas delivery + ventilator fail" alarm.The procedure was continued with a back-up device.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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18138864
• MDR Text Key: 328134273
• Report Number: 9611500-2023-00412
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• 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: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2013
• 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
• Treatment: NA.; NA.