ENTERPRISE 9000X 9X22BW111BCAGB

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 2020-03-30 for ENTERPRISE 9000X 9X22BW111BCAGB manufactured by Arjohuntleigh Polska Sp. Z O.o..

MAUDE Entry Details

Report Number3007420694-2020-00066
MDR Report Key9896557
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-30
Date of Report2020-03-30
Date Mfgr Received2020-03-04
Device Manufacturer Date2015-02-20
Date Added to Maude2020-03-30
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 ContactKINGA STOLINSKA
Manufacturer StreetKS. WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI 62-052
Manufacturer CountryPL
Manufacturer Postal62-052
Manufacturer Phone688282467
Manufacturer G1ARJOHUNTLEIGH POLSKA SP. Z O.O.
Manufacturer StreetUL. KS. PIOTRA WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI PL-62052
Manufacturer CountryPL
Manufacturer Postal CodePL-62052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENTERPRISE 9000X
Generic NameBED, AC-POWERED ADJUSTABLE HOSPITAL
Product CodeFNL
Date Received2020-03-30
Model Number9X22BW111BCAGB
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARJOHUNTLEIGH POLSKA SP. Z O.O.
Manufacturer AddressUL. KS. PIOTRA WAWRZYNIAKA 2 KOMORNIKI PL-62052 PL PL-62052


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-30

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