RAPIDPOINT 500 BLOOD GAS ANALYZER 10697306

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-08-07 for RAPIDPOINT 500 BLOOD GAS ANALYZER 10697306 manufactured by Siemens Healthcare Diagnostics.

MAUDE Entry Details

Report Number3002637618-2019-00090
MDR Report Key8869754
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-08-07
Date of Report2019-08-07
Date of Event2019-07-24
Date Mfgr Received2019-07-24
Date Added to Maude2019-08-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactFELIX AKINRINOLA
Manufacturer Street2 EDGEWATER DRIVE
Manufacturer CityNORWOOD MA 02062
Manufacturer CountryUS
Manufacturer Postal02062
Manufacturer Phone6107052212
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING, LTD.
Manufacturer StreetNORTHERN ROAD CHILTON INDUSTRIAL ESTATE
Manufacturer CitySUDBURY, CO102XQ
Manufacturer CountryUK
Manufacturer Postal CodeCO10 2XQ
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRAPIDPOINT 500 BLOOD GAS ANALYZER
Generic NameRP 500
Product CodeCHL
Date Received2019-08-07
Catalog Number10697306
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-07

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