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Adverse Event Report

AEQUITRON MEDICAL, INC. 9500 HEART RATE/RESPIRATION MONITOR BREATHING FREQUENCY MONITOR   back to search results
Model Number 9500
Event Date 04/07/1997
Event Type  Malfunction   Patient Outcome  Other;
Event Description

During service of product an intermittent apena alarm was found due to an out of calibration condition. Recalibrated respiration setting.

 
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Brand Name9500 HEART RATE/RESPIRATION MONITOR
Type of DeviceBREATHING FREQUENCY MONITOR
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)
AEQUITRON MEDICAL, INC.
14800 28th ave. north
minneapolis MN 55447
Manufacturer (Section D)
AEQUITRON MEDICAL, INC.
14800 28th ave. north
minneapolis MN 55447
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 Key88710
MDR Report Key89730
Event Key84358
Report Number2183157-1997-00117
Device Sequence Number1
Product CodeFLS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/07/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Other
Device MODEL Number9500
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/02/1997
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Device Age2.5 yr
Event Location Not Applicable
Date Manufacturer Received04/07/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/1994
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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