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

Catalog Number 8606500

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

Patient Problem Insufficient Information (4580)

Event Date 12/14/2022

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 the device autonomously switched from pressure controlled ventilation to manual mode during a case.No patient injury reported.

Manufacturer Narrative

Log file evaluation performed by the manufacturer confirms the reported behavior: the supervisor function detected a sporadic loss of the signal from the sensor that monitors the inspiratory cylinder pressure.To protect the patient from potentially hazardous output the device is designed to shut-down automatic ventilation and to post a corresponding "ventilator failure" alarm to alert the user.Manual ventilation with the built-in breathing bag remains possible; the monitoring functions are still available as well.As confirmed for the particular case automatic ventilation could be continued two minutes later.The failure only occurred once without being able to determine the exact root cause for the temporary signal loss of the pressure sensor.As a preventive measure the ventilator assembly and the pcb for ventilation and gas control (including the affected pressure sensor as it is onboard) were replaced.The unit was successfully tested afterwards and was returned to use without further problems reported.Dräger finally concludes that the workstation responded as designed upon the deviation.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 the device autonomously switched from pressure controlled ventilation to manual mode during a case.No patient injury reported.

• Brand Name: APOLLO
• 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: 16136599
• MDR Text Key: 308378926
• Report Number: 9611500-2023-00008
• 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
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1