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 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 Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
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.A ge healthcare service representative performed a checkout of the equipment and confirmed the reported complaint.The wheel and base were replaced to resolve the issue.
 
Event Description
The hospital reported the unit had a caster wheel break off the unit.No patient involvement.
 
Manufacturer Narrative
Additional information was received that only one wheel of the 2 on the caster came off.The caster has two wheels and it will not tip if only one wheel falls off the caster.H3 other text: additional information was received that only one wheel of the 2 on the caster came off.The caster has two wheels and it will not tip if only one wheel falls off the caster.
 
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
MDR Report Key12358496
MDR Text Key269265130
Report Number2112667-2021-01946
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 09/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
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
Date Manufacturer Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-