LIBERATOR 30 13256988

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 2019-02-18 for LIBERATOR 30 13256988 manufactured by Caire Inc..

Event Text Entries

[137434338] The unit has been returned for evaluation. If any new information is discovered, a followup report will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[137434339] Complaint about emptying home lox vessel. After filling of the stroller the qdv valve could not close and the home lox vessel was emptying. The vessel is sent to (b)(4) but the stroller is left at patient's home. The patient is not new and has used this product before. The same event has happened for the same patient approx. 3 weeks earlier. The patient has used this product since (b)(6) 2015 and has changed to side fill vessel from (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004972304-2019-00008
MDR Report Key8348591
Report SourceFOREIGN
Date Received2019-02-18
Date of Report2019-07-24
Date of Event2018-10-09
Date Mfgr Received2019-01-20
Date Added to Maude2019-02-18
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 Received2019-02-18
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 2019-02-18

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