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, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE
  • 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, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE Back to Search Results
Device Problems Complete Blockage (1094); Increase in Pressure (1491)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/09/2020
Event Type  malfunction  
Manufacturer Narrative
Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Patient information could not be obtained due to country privacy laws.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.
 
Event Description
The hospital reported the expiratory valve was blocked during a case resulting in over delivery of pressure.There was no patient injury.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The positive end expiratory pressure valve was replaced to correct this reported fault.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AESPIRE 7100
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key9682939
MDR Text Key210397894
Report Number2112667-2020-00385
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 02/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/10/2020
Initial Date FDA Received02/07/2020
Supplement Dates Manufacturer Received02/17/2020
Supplement Dates FDA Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-