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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. AESPIRE 7900; ANESTHESIA GAS MACHINE Back to Search Results
Model Number 1009-9012-000
Device Problem Inadequate User Interface (2958)
Patient Problem Abrasion (1689)
Event Date 12/27/2017
Event Type  Injury  
Manufacturer Narrative
There is no system malfunction that caused this injury.The unit was returned to service without repair.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.
 
Event Description
The ge healthcare service representative reported the unit was accidentally pushed by another ge healthcare service representative into his right heel.The injured service representative required 30 stitches to his heel.
 
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Brand Name
AESPIRE 7900
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison WI 53718
Manufacturer Contact
joseph seliga
3000 n grandview blvd.
waukesha, WI 53188
MDR Report Key7218974
MDR Text Key98226300
Report Number2112667-2018-00198
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
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1009-9012-000
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/27/2017
Initial Date FDA Received01/25/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/11/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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