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

Device Problems Use of Incorrect Control/Treatment Settings (1126); Loss of Power (1475); Battery Problem (2885); Reset Problem (3019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Results will be provided within a separate follow-up report.

Event Description

It was reported there was a power outage upon going to battery backup, the vent settings went to default.There was no injury reported.

Event Description

Please refer to initial mfr report #9611500-2018-00210.

Manufacturer Narrative

The device is facilitating an electronic log file which consists of two parts - the so-called user log section covering interactions between user and device as well as ventilation-related alarms and the error log section which records conditions like technical errors, pass/fail results of the self-test etc.The device involved in this event remained in use afterwards.The logs were pulled three days after the reported date of occurrence and thus, the user log section was already overwritten for the period in question.The error log contains no entries of technical deviations; there's evidence that the device passed the automatic power-on self-test in the morning of the date of event without deviations.A long-term test was provided to check if it is possible to provoke a return to default settings.In total, 400 power outages were simulated in different ventilation modes but the lab device always continued operation with actual settings.Finally, the root cause for the reported issue could not be found and, comparable cases do not exist.In general, a return to default settings is only possible by a user interaction in standby.There are no possibilities implemented in the device software for an autonomous change of the ventilation settings.A loss of configuration data due to i.E.A malfunction of the control board would result in several entries in the device log, what is not the case here.Furthermore a "loss of data" alarm would be given which would create a log entry, too.The particular event did not result in any patient consequences, reportedly.

• Brand Name: APOLLO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• MDR Report Key: 7604587
• MDR Text Key: 111859360
• Report Number: 9611500-2018-00210
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1