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

Catalog Number 8606500

Device Problems Unexpected Therapeutic Results (1631); Device-Device Incompatibility (2919)

Patient Problem Apnea (1720)

Event Date 02/27/2023

Event Type  malfunction  

Event Description

It was reported that a ventilator failure alarm was posted during use.As per report, patient support was bridged in manual ventilation, the device was restarted in the meantime, passed the automatic self-test w/o deviations and the surgery could be completed without further issues.

Manufacturer Narrative

The device was tested in follow-up of the event by an engineer of the local dräger s&s organization; no persisting technical issues were found.The reported observations could be confirmed upon log file review performed by the manufacturer: the ventilation during the first 1.5 hours of the concerned procedure was stable and unremarkable; from that point in time the peak pressure during application of the breathing strokes continuously increased to attain the same tidal volume.A further 45 minutes later the device started to alarm significant disturbances such as pressure high, pressure limitation, volume not attained and in the following also apnea and fresh gas low or leak.Negative airway pressures were measured and, a pressure peak of 90hpa lead to blockage of the ventilator piston.The device responded as designed and forced a shutdown of automatic ventilation which was accompanied by a corresponding alarm.The entries in the log also confirm that the device was restarted, passed the power-on self-test and was put back into use.Initially, the ventilation was still restricted, the device continued to alarm for pressure high, pressure limitation and volume not attained and, the tidal volume went down to 200ml/min.The operator switched forth and back between the ventilation modes, ventilation stabilized after 15 minutes and stayed uneventful for the remaining 2.5 hours of the procedure.All in all, no indications for the potential presence of technical issues were found.The continuous increase of the airway pressure over a longer period of time was caused by changes of compliance and/or resistance in the pneumatic circuit; most likely those were patient-related.The safety shut-down of ventilation was the device response upon a pressure peak that was - based on experience - generated by a bronchial suction system.This can be considered a use error - the pneumatic circuit of an anesthesia workstation is a closed-loop system and, it is in the nature of things that the application of a vacuum suction system will cause such effects.An additional indicator for the validity of this assessment is the aspect that the device could be used further after the restart.Dräger finally concluded that there is no issue with the device which would require repair or correction - the device posted appropriate alarms to draw the attention of the user to the increasing disturbances of ventilation and responded as designed upon the pressure peak.

• 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: 16625982
• MDR Text Key: 312411416
• Report Number: 9611500-2023-00113
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2013
• 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