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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AESPIRE 7100; ANESTHESIA GAS MACHINE Back to Search Results
Lot Number AMXS00622
Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 06/10/2021
Event Type  malfunction  
Manufacturer Narrative
Legal manufacturer: (b)(4).Patient identifier: no report of patient involvement.Initial reporter address: the initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Legal manufacturer: (b)(4).
 
Event Description
The hospital reported that mechanical ventilation was not available with the device displaying the message "aux gas outlet on".There was no report of patient involvement.
 
Manufacturer Narrative
The ge healthcare service representative performed a check of the system and confirmed the reported issue.The ventilator monitoring board (vmb) was replaced to resolve the reported issue.
 
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Brand Name
AESPIRE 7100
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI 53718
MDR Report Key12131683
MDR Text Key262648153
Report Number2112667-2021-01691
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 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot NumberAMXS00622
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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