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

Catalog Number 8606500

Device Problems Unexpected Therapeutic Results (1631); Component or Accessory Incompatibility (2897); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that there was a ventilator failure during use.There was no injury reported.

Manufacturer Narrative

The ventilator failure described by the user could be reconstructed by means of the logfile analysis.No indications for a device malfunction were found.As further reported, a suction had been used during the reported event.The assumption of the suction being the root cause of the vent failure could be substantiated by logfile analysis: during the case in question, towards the end of the therapy, a fresh gas deficit occurred and the device alarmed repeatedly fresh gas low or leak, pinsp not attained and apnea.Furthermore, negative airway pressures were observed and alarmed accordingly, indicating the usage of a bronchial suction system during use.Following positive and negative pressure peaks were detected, finally leading to a blockade of the ventilator piston.To prevent from damages to the system, the device is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation and the monitoring functions remain available to the full extent.Dräger finally concludes that the device responded as specified upon the detected negative pressure situation with an autonomous shutdown while changing mode to man/spont (safety mode) accompanied by an audible and visible "ventilator fail" alarm.On site, the device was tested by a service technician and no indications for a device malfunction were found either.The device has been returned to use with no further problems reported.

Event Description

It was reported that there was a ventilator failure during use.There was no injury reported.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11206625
• MDR Text Key: 228005853
• Report Number: 9611500-2021-00034
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• 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?: Yes
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.; NA.