STROLLER 11933113

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 2019-02-08 for STROLLER 11933113 manufactured by Caire Inc..

Event Text Entries

[138445907] Unit has been 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


[138445908] Patient reported escape of liquid oxygen from one or both units. Client was unable to reach their supplier (our customer) on the emergency phone line, so called the fire service. Ambulance and police were also called to the scene. The fire service evacuated the building and concluded that there was a fault with a unit. After their own internal inspection of the units, the customer suspects that the portable unit simply iced up during filling due to user error. Update 15th january 2019: internal report from customer (b)(6). Liberator tank was iced up after filling up the stroller portable. Patient couldn't reach their supplier on a saturday so called the emergency services instead. Police, fire and ambulance all attended the scene. Fire service evacuated the building and took the tank outside. They identified a fault with the tank but no further details. A child was taken to hospital. Client contacted the customer after the event and stated that all in the building were in danger of their lives. Update 17th january 2019: the police confirmed that they took no official measures in relation to the incident and that therefore no written record of the incident was made update 5th february 2019: report from fire service of 2nd february. The unit was in the living room, the unit had already iced up significantly at the valve where the oxygen had escaped. The fire officers could not stop the escape of gas, so they took the unit outside to let the rest of the gas out in a controlled manner.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004972304-2019-00003
MDR Report Key8323257
Report SourceFOREIGN
Date Received2019-02-08
Date of Report2019-04-03
Date of Event2018-12-01
Date Mfgr Received2019-01-09
Date Added to Maude2019-02-08
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 NameSTROLLER
Generic NameUNIT, LIQUID OXYGEN, PORTABLE
Product CodeBYJ
Date Received2019-02-08
Returned To Mfg2019-01-09
Model Number11933113
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 2019-02-08

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