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

Device Problems Gas Output Problem (1266); Failure to Analyze Signal (1539); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.We'll provide results in a separate follow-up.

Event Description

It was reported that automatic ventilation failed during use.The device posted a corresponding alarm.There was no injury reported.

Event Description

Please refer to initial mfr.Report #9611500-2020-00081.

Manufacturer Narrative

The reported ventilator failure can be confirmed.The device log file contains two instances of an error code type for the period in question which indicates that the device detected a deviation between measured and expected ventilator motor position.To prevent from damages to the ventilator unit the device is designed to shut down automatic ventilation and to alert the user by means of a corresponding alarm; manual ventilaion as well as the monitoring functions remain available under these conditions.The log file further indicates that the user power-cycled the device which removed the error condition - the procedure could be finished without further irregularities.The log file sequence captures also some following days; the procedures performed during these days went well without problems, too.The motor including the components of the position detection system (encoder disc, light barrier) were replaced as a precautionary measure.The original parts have been tested in detail in the manufacturer's lab but did not exhibit any deviations during the tests.This substantiates the results obtained by log file evaluation: the error condition was of temporary nature only.A reasonable explanation would be that dust on the encoder disc compromized the function of the light barrier and led to intermittent failure to detect the current motor position.A reliable conclusion is however not possible.Dräger finally concludes that the device responded as designed upon this kind of error condition.The user managed the situation by powering the device off and back on.No patient consequences have occurred.

• Brand Name: APOLLO
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9841423
• MDR Text Key: 183779919
• Report Number: 9611500-2020-00081
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1