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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
Device Problem Computer Software Problem (1112)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
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.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 a software watchdog failure preventing mechanical ventilation.There was no report of patient involvement.
 
Manufacturer Narrative
A ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The color control module cpu was replaced to resolve the 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 Key12280364
MDR Text Key267057163
Report Number2112667-2021-01828
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 08/25/2021
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 07/08/2021
Initial Date FDA Received08/05/2021
Supplement Dates Manufacturer Received08/08/2021
Supplement Dates FDA Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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