LIBERATOR 45 13261701

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-05-28 for LIBERATOR 45 13261701 manufactured by Caire Inc..

Event Text Entries

[146279135] Unit has been returned for an evaluation. If any new information is discovered, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[146279136] The patient was filling the portable lox unit from the base unit. The fill nozzle iced up to the extent that the portable unit could no longer be separated from the base unit, and liquid oxygen escaped. In attempting to get the portable unit loose from the base unit, the patient's toes came into contact with liquid oxygen. The patient was taken to hospital and as far as the customer knows she is still an in-patient there. Customer confirms that the patient has been using lox products since (b)(6) 2018 and was trained in proper filling procedures. Whether an error in operation occurred here is not known.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004972304-2019-00032
MDR Report Key8647367
Report SourceFOREIGN
Date Received2019-05-28
Date of Report2019-08-08
Date of Event2019-03-28
Date Mfgr Received2019-04-29
Date Added to Maude2019-05-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
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 45
Generic NameUNIT, LIQUID OXYGEN, STATIONARY
Product CodeBYJ
Date Received2019-05-28
Returned To Mfg2019-05-10
Model Number13261701
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
101. Death; 2. Hospitalization 2019-05-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.