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Adverse Event Report

ALLIED HEALTHCARE PRODUCTS, INC. BEAR 1000 VOLUME VENTILATOR   back to search results
Model Number 1000
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

Loss of sensitivity.

 
Manufacturer Narrative

Defective epi pcb replaced.

 
Search Alerts/Recalls

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Brand NameBEAR 1000
Type of DeviceVOLUME VENTILATOR
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
ALLIED HEALTHCARE PRODUCTS, INC.
2085 rustin ave.
riverside CA 92507
Manufacturer (Section D)
ALLIED HEALTHCARE PRODUCTS, INC.
2085 rustin ave.
riverside CA 92507
Manufacturer (Section G)
BEAR MEDICAL SYSTEMS, INC.
1100 bird center dr.
palm springs CA 92262
Device Event Key96696
MDR Report Key98086
Event Key92235
Report Number2022747-1997-00073
Device Sequence Number1
Product CodeCBK
Report Source Manufacturer
Source Type User facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/16/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/16/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number1000
Device Catalogue Number50-08500-00
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Age4 yr
Event Location Hospital
Date Manufacturer Received05/22/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/1993
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 January 30, 2009

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