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U.S. Department of Health and Human Services

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

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DRAEGERWERK AG & CO. KGAA APOLLO ANESTHESIA UNITS Back to Search Results
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.
 
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Brand NameAPOLLO
Type of DeviceANESTHESIA UNITS
Manufacturer (Section D)
DRAEGERWERK AG & CO. KGAA
moislinger allee 53-55
luebeck, 23542
GM 23542
MDR Report Key7604587
MDR Text Key111859360
Report Number9611500-2018-00210
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042607
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received06/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
Is This a Reprocessed and Reused Single-Use Device? No

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