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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Improper Flow or Infusion (2954); Pressure Problem (3012)

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

Event Date 10/28/2021

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 that during a case the apollo alarmed "reinstall ventilator." no injury reported.

Manufacturer Narrative

The logfile and further information was requested but unfortunately was not made available for the investigation as the device was serviced by a third-party vendor.In general, a reinstall vent alarm indicates a restricted ventilation capability of the ventilator, the possible causes can be manifold.It can be caused by an inspiratory volume error, what means that the tidal volume measured by the inspiratory flow sensor differs at least 25% from the tidal volume applied by the ventilator, a loss of vacuum pressure inside the ventilator piston, e.G.Caused by a faulty diaphragm, a significant leakage in the patient system or the presence of expiratory gas flow during inspiration, e.G.Caused by a sticking valve.A likely root cause is a loose inspiratory elbow nozzle causing a leak between the flow sensor and the breathing system block, which is detected by the device and alarmed immediately.However, in all cases automatic ventilation is restricted.Manual ventilation as well as monitoring functionality is not affected.Based on the available information the exact root cause can¿t be determined.The device alarmed correctly and according to its safety concept for reinstall vent.

Event Description

It was reported that during a case the apollo alarmed "reinstall ventilator." 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: 12776713
• MDR Text Key: 281319838
• Report Number: 9611500-2021-00457
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2011
• 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.