ATMOSAIR 9000 A9MRLVG35083TMS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-25 for ATMOSAIR 9000 A9MRLVG35083TMS manufactured by Arjohuntleigh Polska Sp. Z O.o..

MAUDE Entry Details

Report Number3007420694-2019-00175
MDR Report Key9237375
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-10-25
Date of Report2019-11-22
Date of Event2019-09-23
Date Mfgr Received2019-10-02
Device Manufacturer Date2019-06-24
Date Added to Maude2019-10-25
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 ContactMS KINGA STOLINSKA
Manufacturer StreetUL. KS. WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI, 62-052
Manufacturer CountryPL
Manufacturer Postal62-052
Manufacturer G1ARJOHUNTLEIGH POLSKA SP. Z O.O.
Manufacturer StreetUL. KS. WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI, 62-052
Manufacturer CountryPL
Manufacturer Postal Code62-052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameATMOSAIR 9000
Generic NameMATTRESS, FLOTATION THERAPY, NON-POWERED
Product CodeIKY
Date Received2019-10-25
Model NumberA9MRLVG35083TMS
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARJOHUNTLEIGH POLSKA SP. Z O.O.
Manufacturer AddressUL. KS. WAWRZYNIAKA 2 KOMORNIKI, 62-052 PL 62-052


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-25

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