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Adverse Event Report

BEAR MEDICAL SYSTEMS BEAR VOLUME VENTILATOR   back to search results
Model Number BEAR 5
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Hosp reports of no flow to pt. No pt injury noted.

 
Manufacturer Narrative

Field service technician found partially blocked external flow filter. Technician removed the obstructed flow filter and ran a self-check on ventilator; with no further failures. F-10: no pt info.

 
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
2085 rustin ave.
riverside CA 92507
Manufacturer (Section D)
BEAR MEDICAL SYSTEMS
2085 rustin ave.
riverside CA 92507
Manufacturer (Section G)
BEAR MEDICAL SYSTEMS, INC.
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
william seward
1100 bird center drive
palm springs , CA 92262
(760) 883 -7121
Device Event Key140118
MDR Report Key143660
Event Key134953
Report Number2022747-1998-00016
Device Sequence Number1
Product CodeCBK
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 01/14/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/14/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberBEAR 5
Device Catalogue Number50000-00711
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Device Age4.5 yr
Event Location Hospital
Date Manufacturer Received12/19/1997
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/1992
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Database last updated on February 28, 2009

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