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Adverse Event Report

QELLCOR PURITAN BENNETT   back to search results
Model Number 9500
Event Date 03/04/1998
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Nellcor puritan bennett received a call from rptr on 3/4/1998. He had called to report the following: alarm not working properly.

 
Manufacturer Narrative

Na.

 
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Baseline Brand NameMODEL 9500 RESPIRATION/HEARTRATE MONITOR
Baseline Generic NameMONITOR RESPIRATORY/APNEA
Baseline Catalogue NumberNA
Baseline Model Number9500
Baseline Device FamilyBREATHING FREQUENCY MONITOR
Baseline Device 510(K) NumberK903020
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed07/01/1987
Manufacturer (Section F)
QELLCOR PURITAN BENNETT
2800 northwest blvd.
minneapolis MN 55441
Manufacturer (Section D)
QELLCOR PURITAN BENNETT
2800 northwest blvd.
minneapolis MN 55441
Manufacturer (Section G)
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
2800 northwest blvd.
plymouth MN 55441
Manufacturer Contact
robert samec
14800 28th ave n
minneapolis , MN 55447
(612) 557 -9200
Device Event Key157489
MDR Report Key161747
Event Key152015
Report Number2183157-1998-00059
Device Sequence Number1
Product CodeFLS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 04/03/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/1998
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device MODEL Number9500
OTHER Device ID Number355443-001
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/17/1998
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Agena
Event Location Not Applicable
Date Manufacturer Received03/04/1998
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/1995
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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