• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS PLUS ANESTHESIA UNITS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DRÄGERWERK AG & CO. KGAA FABIUS PLUS ANESTHESIA UNITS Back to Search Results
Catalog Number 8606800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hypoventilation (1916); Hypoxia (1918)
Event Date 12/15/2018
Event Type  Injury  
Manufacturer Narrative

On-site evaluation in follow-up of the event revealed no nonconformities. In-depth analysis has just started, results will be provided in a follow-up report.

 
Event Description

It was reported to dräger that a patient became hypoxic during an anesthetic procedure. The user stated that the device did not alarm. The patient died.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFABIUS PLUS
Type of DeviceANESTHESIA UNITS
Manufacturer (Section D)
DRÄGERWERK AG & CO. KGAA
moislinger allee 53-55
lübeck 23542
GM 23542
Manufacturer Contact
sonja hillmer
moislinger allee 53-55
lübeck 23542
GM   23542
4518822868
MDR Report Key8183798
MDR Text Key130973896
Report Number9611500-2018-00413
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
PMA/PMN Number-
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 02/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/01/2000
Device Catalogue Number8606800
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/30/2009
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: 12/20/2018 Patient Sequence Number: 1
-
-