• 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 VIEW; 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 VIEW; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
Manufacturer Narrative
The unit was evaluated by the end user after the procedure and it was found that the unit had "poor contact around the anesthesia machine switch".The exact switch was not mentioned.The switch was unplugged and then plugged.A loose connection of the on/standby switch could have caused an intermittent shutdown issue.The repair of re-plugging in the switch, to ensure a tight fit, resolved the reported fault.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.Unique identifier: (b)(4).Legal manufacturer: (b)(4).
 
Event Description
Per (b)(6) aer database: it was reported the display went blank and the unit shutdown during patient use.There is no report of patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AESPIRE VIEW
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
Manufacturer Contact
anthony amenson
MDR Report Key13114349
MDR Text Key286874125
Report Number2112667-2021-02917
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K172045
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 12/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/02/2021
Date Device Manufactured01/02/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
-
-