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 05/18/2022

Event Type  malfunction  

Event Description

It was reported during a case the unit alarmed for a ventilator failure.There was no injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

The ventilator failure described by the user could be reconstructed by means of the logfile analysis.No indications for a device malfunction leading to the vent fail were found.Root cause for the reported symptom was an overpressure at the patient end of the circuit leading to a pressure peak.Most likely, the patient was coughing against the ventilator explaining the pressure peak.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.During on-site checking in follow-up to the event, problems with the ventilator motor were found by the dräger technician and the motor was replaced consequently.Based on earlier complaint investigations, it could be stated that the determined worn motor assembly was caused by wear-and-tear related abrasion of the collector disc resulting in development of positions where the motor does not provide mechanic power due to contact interrupts to the carbon brushes; speed fluctuations will be the consequence.These speed fluctuations may result in a deviation between intended and expected piston position.This will be detected during service, as reported in the particular case, or during pre-use check.In the particular case however, the pressure peak led to the reported ventilator failure.Dräger finally concludes that the device responded as specified upon the detected pressure peak situation ¿ likely caused by the patient coughing or breathing against the ventilator ¿ with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.After replacement of the motor, the device was tested and returned to use with no further problems reported.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 during a case the unit alarmed for a ventilator failure.There was no 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: 14571883
• MDR Text Key: 297361003
• Report Number: 9611500-2022-00132
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• 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: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2008
• 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