LIBERATOR 30 11034054

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-09-07 for LIBERATOR 30 11034054 manufactured by Caire Inc..

Event Text Entries

[119649599] Unit is getting returned for evaluation by manufacturer. If any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[119649600] Vessel was emptying itself after filling patients stroller. The patient has done everything according to the instruction
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004972304-2018-00041
MDR Report Key7857287
Report SourceDISTRIBUTOR,FOREIGN
Date Received2018-09-07
Date of Report2019-02-27
Date Mfgr Received2018-08-10
Date Added to Maude2018-09-07
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 ContactMR. NEAL MALOY
Manufacturer Street2200 AIRPORT INDUSTRIAL DRIVE SUITE 500
Manufacturer CityBALL GROUND GA 30107
Manufacturer CountryUS
Manufacturer Postal30107
Manufacturer G1CAIRE INC.
Manufacturer Street2200 AIRPORT INDUSTRIAL DRIVE SUITE 500
Manufacturer CityBALL GROUND GA 30107
Manufacturer CountryUS
Manufacturer Postal Code30107
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIBERATOR 30
Generic NameUNIT, LIQUID-OXYGEN
Product CodeBYJ
Date Received2018-09-07
Returned To Mfg2019-02-15
Model Number11034054
OperatorLAY USER/PATIENT
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCAIRE INC.
Manufacturer Address2200 AIRPORT INDUSTRIAL DRIVE SUITE 500 BALL GROUND GA 30107 US 30107


Patients

Patient NumberTreatmentOutcomeDate
10 2018-09-07

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