SPIRIT 1200 SF 12944586

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-17 for SPIRIT 1200 SF 12944586 manufactured by Caire Inc..

Event Text Entries

[188211916] A technician filled up the base unit (liberator 45) at a patient's house. The patient's wife called the technician 30 minutes after he left, saying the unit was empty again and needed to be refilled. On site, the technician was told that when filling the portable unit (spirit), it iced up and the valve did not close, so the base unit subsequently emptied. The technician checked both devices when refilling, but could not find the root cause for it icing up. The patient stated that he was in a hurry to fill up the portable, and it jammed. He tried to separate the portable unit from the base unit anyway, and the valve did not close anymore. The patient suffered a slight burn on the hand. The technician could not find any fault with the units, so they remained with the patient. The patient and his wife were both re-instructed on how to use the units, including before filling (temperature compensation and drying) and when the valve does not close. The patient has been supplied with oxygen since (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004972304-2020-00007
MDR Report Key9716612
Report SourceDISTRIBUTOR
Date Received2020-02-17
Date of Report2020-02-17
Date of Event2019-08-05
Date Mfgr Received2020-01-21
Device Manufacturer Date2016-08-23
Date Added to Maude2020-02-17
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 Phone7707217700
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 NameSPIRIT 1200 SF
Generic NameUNIT, LIQUID OXYGEN, PORTABLE
Product CodeBYJ
Date Received2020-02-17
Model Number12944586
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
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. Other 2020-02-17

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