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 7900; 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 7900; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2019
Event Type  malfunction  
Manufacturer Narrative
No report of patient involvement.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare's investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.
 
Event Description
The hospital reported an error that results in the loss of mechanical ventilation.There was no report of patient injury.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The sensor interface board was replaced, and the unit was returned to service.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AESPIRE 7900
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key9530524
MDR Text Key217128277
Report Number2112667-2019-02745
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K050626
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 01/02/2020
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 12/01/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received01/02/2020
Supplement Dates FDA Received01/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-