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Adverse Event Report

BEAR MEDICAL SYSTEMS BEAR VOLUME VENTILATOR   back to search results
Model Number BEAR 5
Device Problem Cycle, failure to
Event Date 12/16/1999
Event Type  Malfunction  
Manufacturer Narrative

Service inspected unit and can not duplicate failure.

 
Event Description

Vent inop with flow sensor failure.

 
Search Alerts/Recalls

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Brand NameBEAR
Type of DeviceVOLUME VENTILATOR
Baseline Brand NameBEAR
Baseline Generic NameVOLUME VENTILATOR
Baseline Catalogue Number50000-00711
Baseline Model NumberBEAR 5
Baseline Device FamilyBEAR 5
Baseline Device 510(K) NumberK840119
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed04/01/1984
Date Ceased Marketing01/01/1994
Manufacturer (Section F)
BEAR MEDICAL SYSTEMS
1100 bird center dr.
palm springs CA 92262
Manufacturer (Section D)
BEAR MEDICAL SYSTEMS
1100 bird center dr.
palm springs CA 92262
Manufacturer (Section G)
BEAR MEDICAL SYSTEMS
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
darryl shelby
1100 bird center drive
palm springs , CA 92262
(760) 778 -7200 ext 614
Device Event Key249849
MDR Report Key258013
Event Key241828
Report Number2022747-2000-00007
Device Sequence Number1
Product CodeCBK
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 01/10/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/10/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberBEAR 5
Device Catalogue Number50000-00711
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age7 yr
Event Location Hospital
Date Manufacturer Received12/21/1999
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/01/1993
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 January 30, 2009

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