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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2023

Event Type  malfunction  

Event Description

It was reported that during use of automatic ventilation, when connecting the inoflo connector to the inspiratory side, the device alarmed for "ventilator fail" and switched to manual ventilation.Switching back to automatic ventilation was, as further reported, not possible.There was no patient consequences reported.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Manufacturer Narrative

The electronic device logfile was provided for investigation.Unfortunately, the user section of the logfile was already overwritten for the given date (2023-06-23).Thus, the case in question could not be reconstructed in detail.According to the device log records, it could be confirmed that on the date of event, the ventilator performed an emergency shutdown due to a detected overpressure at the patient end of the circuit leading to a pressure peak.Most likely, the overpressure situation was caused by the surgical therapy, but also a patient coughing against the ventilator could explain the pressure peak.A connection between the usage of the inoflo system in combination with the apollo and the reported symptom could neither be confirmed nor excluded on the basis of the available information.To prevent from damages, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes that the device responded as specified upon the detected situation with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.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 during use of automatic ventilation, when connecting the inoflo connector to the inspiratory side, the device alarmed for "ventilator fail" and switched to manual ventilation.Switching back to automatic ventilation was, as further reported, not possible.There was no patient consequences 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17348827
• MDR Text Key: 319419789
• Report Number: 9611500-2023-00263
• 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
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8606500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2009
• 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