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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATEX-OHMEDA, INC. AESTIVA 7100 ANESTHESIA GAS MACHINE

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DATEX-OHMEDA, INC. AESTIVA 7100 ANESTHESIA GAS MACHINE Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 08/08/2016
Event Type  Malfunction  
Manufacturer Narrative

The biomedical engineer troubleshot the replacement of the caster with ge healthcare technical support. The caster wheel was recommended for replacement. No report of patient involvement.

 
Event Description

The hospital reported the caster wheel on the back left of the unit had come out. There was no report of patient involvement.

 
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Brand NameAESTIVA 7100
Type of DeviceANESTHESIA GAS MACHINE
Manufacturer (Section D)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer (Section G)
DATEX-OHMEDA, INC.
3030 ohmeda drive
madison WI 53718
Manufacturer Contact
john szalinski
540 w. northwest highway
barrington, IL 60010
MDR Report Key5920870
MDR Text Key53691202
Report Number2112667-2016-01693
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK000706
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 09/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/01/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/08/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/07/2001
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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