LIBERATOR 30 13256988

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 13256988 manufactured by Caire Inc..

Event Text Entries

[119652334] 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


[119652335] The vessel was emptying itself after filling of patient stroller. The qdv valve was not dried after filling of strollers and could not close. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004972304-2018-00038
MDR Report Key7856989
Report SourceDISTRIBUTOR,FOREIGN
Date Received2018-09-07
Date of Report2018-09-07
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, STATIONARY
Product CodeBYJ
Date Received2018-09-07
Returned To Mfg2019-02-15
Model Number13256988
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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