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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. IVENT 201 CRITICAL CARE VENTILATER

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DATEX-OHMEDA, INC. IVENT 201 CRITICAL CARE VENTILATER Back to Search Results
Model Number M1161857
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2018
Event Type  malfunction  
Manufacturer Narrative
The customer biomedical engineer troubleshot the issue with ge healthcare technical support. It was recommended to fully charge the batteries and re-calibrate the battery level indicator. Patient information could not be obtained after multiple attempts. Attempts were made as follows: 2/23/18 phone call, 2/26/18 phone call, 2/17/18 phone call. Date of device manufacture was unavailable at time of mdr filing.
 
Event Description
The hospital reported that the unit shut down and is not holding a charge. There was no report of patient injury.
 
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Brand NameIVENT 201
Type of DeviceCRITICAL CARE VENTILATER
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda dr,
madison, WI
Manufacturer Contact
john szalinski
3000 n grandview blvd.
waukesha, WI 
MDR Report Key7309173
MDR Text Key101359334
Report Number2112667-2018-00452
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 03/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberM1161857
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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