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Adverse Event Report

ALLIED HEALTHCARE PRODUCTS INC. BEAR 5 VENTILATOR   back to search results
Model Number 13600
Event Date 05/21/1997
Event Description

Ventilator went inoperative without power failure, staff present, pt immediately manually ventilated.

 
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Brand NameBEAR 5
Type of DeviceVENTILATOR
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)
ALLIED HEALTHCARE PRODUCTS INC.
2085 rustin avenue
riverside CA 92507
Manufacturer (Section D)
ALLIED HEALTHCARE PRODUCTS, INC.
2085 rustin ave.
riverside CA 92507
Device Event Key98790
MDR Report Key100276
Event Key94313
Report Number100276
Device Sequence Number1
Product CodeCBK
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/22/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/25/1997
Is This An Adverse Event Report? No
Device Operator Health Professional
Device MODEL Number13600
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/21/1997
Device Age10 yr
Event Location Other
Date Report TO Manufacturer05/23/1997
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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