FDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health [Skip navigation]
horizonal rule
Super Search
510(k) | Registration & Listing | Adverse Events | PMA | Classification | CLIA
CFR Title 21 | Advisory Committees | Assembler | Recalls | Guidance | Standards
 

 

Adverse Event Report

DATEX-OHMEDA AESTIVA 3000 ANESTHESIA MACHINE   back to search results
Model Number AESTIVA 3000
Event Date 10/25/2002
Event Type  Malfunction  
Event Description

Customer reported the bag-to-vent switch was not operational. There was no reported patient injury. Datex-ohmed's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed. Receipt of additional information - 01/13/03.

 
Manufacturer Narrative

Investigation/conclusion: the parts returned to the manufacturing site for investigation. It was determined there was interference between two metric screws, the toggle shaft, and the pivot bracket. This resulted in improper installation and bending of the screws with subsequent fracture of the screws under normal usage. Assembly personnel have been informed of this complaint. Additionally, certain tolerances for the involved parts have since been tightened as well as teh counterbore diameter of the screw holes has been enlarged.

 
Search Alerts/Recalls

  new search  |  submit an adverse event report

Brand NameAESTIVA 3000
Type of DeviceANESTHESIA MACHINE
Baseline Brand NameAESTIVA 3000
Baseline Generic NameANESTHESIA MACHINE
Baseline Catalogue Number1006-9300-000
Baseline Model NumberAESTIVA 3000
Baseline Device FamilyANESTHESIA MACHINE
Baseline Device 510(K) NumberK973896
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed04/01/1998
Manufacturer (Section F)
DATEX-OHMEDA
ohmeda dr.
madison WI 53707
Manufacturer (Section D)
DATEX-OHMEDA
ohmeda dr.
madison WI 53707
Manufacturer (Section G)
DATEX-OHMEDA (MADISON)
ohmeda drive
madison WI 53707
Manufacturer Contact
cathy johnson, spec.
ohmeda drive
madison , WI 53707
(608) 221 -1551
Device Event Key427855
MDR Report Key438932
Event Key415404
Report Number2112667-2003-00007
Device Sequence Number1
Product CodeBSZ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial,Followup
Report Date 01/15/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/16/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberAESTIVA 3000
Device Catalogue Number1006-9300-000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/25/2002
Event Location Hospital
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/1999
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH