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 Insufficient Information (4580)

Event Date 07/18/2022

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 there was a vent fail message posted.No injury reported.

Manufacturer Narrative

A dräger service engineer has examined the device on-site in follow-up of the first event occurred on july 18th which was reported under 9611500-2022-00208.Based on an initial log file analysis the position detection system for the ventilator motor as well as the motor itself were checked and were found working according to specifications.The device was tested in several ventilation modes and did not exhibit deviations from specification - it was thus released for further use.The user reported a new occurrence of the failure for (b)(6) (9611500-2022-00213) whereupon it was decided to replace the ventilator motor including the position detection system.The replaced parts were not released by the user facility for an in-depth evaluation upon a related request.Hence, the manufacturer's evaluation was based on the findings made by the service engineer and on analysis of the provided log file.The log file demonstrates evidence that the device passed the power-on self-test (post) in the early morning of the first date of event without deviations.The concerned procedure ran with unremarkable and stable ventilation for the first 2 hours and 45 minutes until the supervisor software detected a divergence between measured and calculated ventilator piston position.A shut-down of automatic ventilation was forced as defined in the device's safety concept; a corresponding "vent fail" alarm was posted.The user power-cycled the device; the next instance of the post was passed and, the device was put into operation again.The error condition however recurred after another ten minutes and, the user continued the procedure in manual ventilation until the end.The course of the second event happened three days later basically equals to the first event.The following can be concluded: the workstation facilitates a piston ventilator driven by a motor.Rotation speed and angle of the motor are being monitored continuously as these parameters define the piston hub and the tidal volumes that are applied.Significant divergences between expected and measured piston position will trigger a shut-down of automatic ventilation for safety reasons to protect the patient from potentially hazardous output.These divergences can have various root causes including issues with the ventilator motor, the control electronics or any damage to the surrounding components that result in a hinderance of motor rotation.It can be related to the position detection system i.E.Incorporate indeed a measuring problem only.Finally, the safety shut-down of ventilation is not necessarily related to a device malfunction - it may be the response to a fast and significant airway pressure rise as it typically occurs during repositioning of the patient or when the patient is coughing against a piston hub.A differentiation between these scenarios is not possible due to lack of information.Absence of clear indications for technical issues would rather point to a triggering condition which is related to the procedure or the patient.However, all components that may be put in causal connection to the reported events have been replaced, the device was tested to verify proper operation and returned to use.

Event Description

It was reported there was a vent fail message posted.No injury reported.Remark: the device reportedly failed during two different surgical procedures.Two mdrs were filed, consequently.The second corresponding report is 9611500-2022-00213.

• 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: 15239663
• MDR Text Key: 303247561
• Report Number: 9611500-2022-00208
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• 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: 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2009
• 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
• Treatment: NA.; NA.