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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Manufacturer Narrative

The hospital's biomed was seeking dräger's assistance on the phone; the technical support team guided him through the device evaluation procedure to identify the root cause for the ventilator failure.It was noticed that debris on the motor encoder disc had formed.The disc was cleaned; the device has been tested after reassembly and, no further deviation from specification was detected.The unit has been returned to use with no new issues reported to date.The log file was analyzed in follow-up by the manufacturer.The records confirm both the reported event as well as the findings and conclusions made by the biomed in cooperation with dräger's tech support.The device had passed the automatic power-on self-test (post) in the morning of the doe without deviations.The concerned procedure was started at 10:42 pm.The first few minutes in automatic ventilation were unremarkable until the device detected a wrong motor position at 11:00 pm.As designed the unit forced a safety shutdown of automatic ventilation and posted a corresponding alarm.The user restarted the device, skipped the next post instance and used the device for the next 1.5 hours in pressure support mode without further problems.Based on these records a causal connection between the shutdown of ventilation and the debris found on the encoder disc later-on seems plausible.Motor speed and the number of rotations must be monitored continuously as they define the ventilator piston hub and thus, the tidal volume applied to the patient.The motor has an encoder wheel on its axis which has markings that pass by a light barrier during motor rotation.With debris on the encoder disc the position detection may be impaired.To protect the patient from potentially hazardous output the device is designed to shut-down automatic ventilation and to alert the user to this condition by means of an alarm.Manual ventilation and the monitoring functions remain available to the full extend.Dräger finally concludes that the device responded as designed upon a certain error condition.The origin of the debris could not be determined, retrospecitvely.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 a ventilator failure occurred during a surgical procedure.It was mentioned that this did not lead to consequences for the patient.

• 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: 16324409
• MDR Text Key: 309130191
• Report Number: 9611500-2023-00045
• 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
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2015
• 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