Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA ENGSTROM; RESPIRATORY CARE VENTILATOR
  • 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
 

DATEX-OHMEDA ENGSTROM; RESPIRATORY CARE VENTILATOR Back to Search Results
Device Problems Increase in Pressure (1491); Tidal Volume Fluctuations (1634)
Patient Problem Cardiac Arrest (1762)
Event Date 12/15/2013
Event Type  Injury  
Event Description
The hospital reported the unit alarmed for high peak pressure and tidal volume delivered was noted to be lower than the set tidal volume.It was further reported that the pt went into cardiac arrest.
 
Manufacturer Narrative
Under european law, pt info is considered confidential and will not be released by the hospital.Ge healthcare's investigation into the reported event is still ongoing.A follow-up report will be issued when the investigation has been completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ENGSTROM
Type of Device
RESPIRATORY CARE VENTILATOR
Manufacturer (Section D)
DATEX-OHMEDA
madison WI
Manufacturer (Section G)
DATEX-OHMEDA INC
madison WI
Manufacturer Contact
joy sonsalla
3000 n. grandview bldg.
w450
waukesha, WI 53188
2625482661
MDR Report Key3595383
MDR Text Key4093583
Report Number2112667-2014-00004
Device Sequence Number1
Product Code DRT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K041775
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/17/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-