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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.
 
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Brand NameAPOLLO
Type of DeviceANESHESIA 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
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 Treatment Data
Date Received: 07/16/2021 Patient Sequence Number: 1
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