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

Catalog Number 8606500

Device Problems Gas Output Problem (1266); Failure to Sense (1559); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2019

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 the ventilator failed during a case.The patient was bagged and the case was completed.There was no patient injury reported.

Event Description

Please refer to initial mfr.Report #9611500-2019-00339.

Manufacturer Narrative

A dräger service technician was dispatched who examined the device and - based on log file analysis - replaced the entire ventilator motor unit including the position detection system.The device passed all the consecutive tests and was returned to use.The log file was subject to detailed analysis by the manufacturer.The results confirm the initial expertise: the workstation is equipped with a piston ventilator.The motor position is subject to continuous monitoring by the supervisor software to avoid damages i.E.To prevent from piston moving against the mechanical stops at lower and upper positions.If the position detection system fails to detect a certain number of increments, automatic ventilation will be shut down and a corresponding alarm will be posted.Manual ventilation remains possible and the monitoring functionalities of the workstation are still available as well.Dräger finally concludes that the workstation responded as designed upon a deviation detected by the supervisor function.The problem was fully resolved by replacement of the motor assembly.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• MDR Report Key: 9206327
• MDR Text Key: 186751374
• Report Number: 9611500-2019-00339
• 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
• Type of Report: Initial,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• 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: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1