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 02/11/2022

Event Type  malfunction  

Manufacturer Narrative

A draeger technician evaluated the device and the device log file.During testing the device displayed an expiratory flow sensor failure; the customer changed the flow sensor then.The tests were repeated and completed with no further issues.The records in the log file indicate a sudden drop in airway pressure which was not caused by the device itself.Based on experience, this happens when a bronchial suction system is being used intraoperatively.The device responds to this condition with a shut-down of automatic ventilation for safety reasons.The hospital's biomed could neither confirm nor deny that a suction maneuver was performed but this theory is substantiated by the fact that no persisting error condition of the ventilator unit was found when the device was tested in follow-up of the event.The flow sensor issue cannot be put in causal connection to a ventilator failure; it is just the end of life of a consumable accessory which affects monitoring functionality only.It may have occurred after the ventilator shut-down during the period of following manual ventilation.

Event Description

It was reported during a case that the unit displayed a ventilator failure message and only manual ventilation could be used.There was no patient 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: 13857089
• MDR Text Key: 297318583
• Report Number: 9611500-2022-00080
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2014
• 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