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

Catalog Number 8606500

Device Problem No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2018

Event Type  malfunction  

Manufacturer Narrative

The case in question reportedly occurred on (b)(6) 2018.As the device remained in use after the event and the log file only was downloaded on (b)(6) 2018 the user section for the relevant day was overwritten already.Therefore the log analysis was performed based on the device section records.According to these the power-on self-test (post) was successfully completed in the morning of the reported date of event.During the suspected time of event at 4:09pm a wrong motor position was detected by the ventilator.The device behaved as specified for this failure with an autonomous shutdown while changing mode to man/spont accompanied by an audible and visible "ventilator fail" alarm.In this case manual ventilation remains possible.At 4:33pm and 4:41pm the device was rebooted and each subsequent performed post was completed without findings.The motor assembly was replaced as a precaution.Based on the device log (as the user log was overwritten already) the root cause could not be determined in detail unfortunately.Finally the device was tested and was returned to use without further problems reported.

Event Description

It was reported there was a ventilator failure with the apollo machine.There was no injury to the patient reported.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• Manufacturer (Section G): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• MDR Report Key: 7761084
• MDR Text Key: 116373745
• Report Number: 9611500-2018-00250
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2012
• 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