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Adverse Event Report

DATEX-OHMEDA, INC. AESTIVA 3000 ANESTHESIA MACHINE   back to search results
Model Number AESTIVA 3000
Event Date 06/28/2001
Event Type  Malfunction  
Event Description

Customer reported difficulty in operating the bag-to-vent switch. There was no reported patient injury. Datex-ohmeda's investigation into the reported occurence is still ongoing. A follow-up report will be issued when the investigation has been completed.

 
Manufacturer Narrative

Investigation/conclusion: the parts were returned to the mfg 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 the counterbore diameter of the screw holes has been enlarged.

 
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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, INC.
ohmeda drive
madison WI 53707
Manufacturer (Section D)
DATEX-OHMEDA, INC.
ohmeda drive
madison WI 53707
Manufacturer Contact
cathy johnson, spec.
ohmeda drive
madison , WI 53707
(608) 221 -1551
Device Event Key331766
MDR Report Key342430
Event Key322466
Report Number2112667-2001-00056
Device Sequence Number1
Product CodeBSZ
Report Source Manufacturer
Source Type User facility
Reporter Occupation Invalid Data
Type of Report Initial,Followup
Report Date 07/12/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2001
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
Device LOT NumberNONE
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/28/2001
Event Location Hospital
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2000
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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