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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA APOLLO; ANESHESIA UNITS
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DRÄGERWERK AG & CO. KGAA APOLLO; ANESHESIA UNITS Back to Search Results
Catalog Number 8605310
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Hypoxia (1918); Brain Injury (2219)
Event Date 06/11/2021
Event Type  Injury  
Manufacturer Narrative
The investigation has just started; results will be provided in a follow-up report.
 
Event Description
The customer had originally requested a dräger technician to download the device log file and provide a log review.During the technician's on-site visit it had been conveyed that there was a patient injury (hypoxic brain trauma).There has been no alleged device malfunction; further details about the course of event are currently not known.The event is being reported in abundance of caution since a use error cannot be fully excluded at this time.
 
Manufacturer Narrative
The electronic device logfile was available for investigation.Unfortunately, the user section was already overwritten as well as the device log records prior to 11:32am (it was reported the case took place between 10:42am and 11:40am).Thus, a reconstruction of the case in question was not possible.According to the device log, at 11:48am, 3:39pm and 7:23pm minute volume leaks of 0.5 to 0.7 l/min were measured indicating the presence of an external leakage in the patient circuit.No further relevant entries were recorded for the date in question.The evaluation revealed no indications for a technical malfunction.In case an external leakage is present prior to use, it will be detected during the power-on self-test as well as during the leak-test.During use, an external leakage will be alarmed accordingly.In general, the apollo is equipped with an integrated pressure-, volume- and patient gas monitoring that ensures that deviations from set/expected parameters are obvious and will be alarmed depending on the limits adjusted by the user.Finally, no indications for a device malfunction were found.As the user also did not allege a device malfunction to be in causal connection to the reported injury and as there are no hints for an inappropriate user handling in connection with the device, the case was assessed as not reportable and should not have been reported, if known before.
 
Event Description
The customer had originally requested a dräger technician to download the device log file and provide a log review.During the technician's on-site visit it had been conveyed that there was a patient injury (hypoxic brain trauma).There has been no alleged device malfunction; further details about the course of event are currently not known.The event is being reported in abundance of caution since a use error cannot be fully excluded at this time.
 
Manufacturer Narrative
Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.
 
Event Description
The customer had originally requested a dräger technician to download the device log file and provide a log review.During the echnician's on-site visit it had been conveyed that there was a patient injury (hypoxic brain trauma).There has been no alleged device malfunction; further details about the course of event are currently not known.The event is being reported in abundance of caution since a use error cannot be fully excluded at this time.
 
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Brand Name
APOLLO
Type of Device
ANESHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck
GM 
Manufacturer (Section G)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM   23542
MDR Report Key12180329
MDR Text Key262165907
Report Number9611500-2021-00311
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 User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 05/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number8605310
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/30/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Disability;
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