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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. ALADIN II; ANESTHESIA GAS MACHINE
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DATEX-OHMEDA, INC. ALADIN II; ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problems Blurred Vision (2137); No Consequences Or Impact To Patient (2199)
Event Date 04/11/2018
Event Type  malfunction  
Manufacturer Narrative
Inspection of the equipment noted that one of the pins inside the cassette filling mechanism was bent.The pin was repaired.Patient information could not be obtained due to country privacy laws.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.
 
Event Description
While servicing the anesthetic agent cassette, agent sprayed in the eyes of the gehc service representative, resulting in temporary blurry vision.A cleaning solution was used to remove the agent from the representative's eyes.
 
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Brand Name
ALADIN II
Type of Device
ANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7484441
MDR Text Key107323967
Report Number2112667-2018-00906
Device Sequence Number1
Product Code BSZ
Combination Product (y/n)N
PMA/PMN Number
K042154
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial
Report Date 05/03/2018
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
Other Device ID NumberSEE H10
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/11/2018
Initial Date FDA Received05/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/26/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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