RADICAL-7 HANDHELD 22545 9500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-05 for RADICAL-7 HANDHELD 22545 9500 manufactured by Masimo - 52 Discovery.

Event Text Entries

[182910835] Additional manufacturing narrative: attempts have been made to obtain the product. The product has not been returned to masimo to allow an analysis to be performed. If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[182910836] The customer reported high sphb values when compared to a blood draw. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011353843-2020-00032
MDR Report Key9795308
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-05
Date of Report2020-02-10
Date of Event2020-02-10
Date Mfgr Received2020-02-10
Device Manufacturer Date2013-07-26
Date Added to Maude2020-03-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEFAN LISSMANN
Manufacturer Street52 DISCOVERY
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9492977168
Manufacturer G1MASIMO - MEXICALI
Manufacturer StreetINDUSTRIAL VALLERA DE MEXICALI CALZADA DEL ORO, NO.2001
Manufacturer CityMEXICALI, BAJA CALIFORNIA 21600
Manufacturer CountryMX
Manufacturer Postal Code21600
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRADICAL-7 HANDHELD
Generic NameOXIMETER
Product CodeDQA
Date Received2020-03-05
Model Number22545
Catalog Number9500
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMASIMO - 52 DISCOVERY
Manufacturer Address52 DISCOVERY IRVINE CA 92618 US 92618


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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