QS820 MANUAL BED IH820

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-08 for QS820 MANUAL BED IH820 manufactured by Invacare Florida Operations.

Event Text Entries

[25816009] Should additional information become available a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1031452-2015-15852
MDR Report Key5060240
Date Received2015-09-08
Date of Report2015-08-12
Date Mfgr Received2015-08-12
Date Added to Maude2015-09-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKEVIN GUYTON
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1INVACARE FLORIDA OPERATIONS
Manufacturer Street2101 EAST LAKE MARY BLVD
Manufacturer CitySANFORD FL 32773
Manufacturer CountryUS
Manufacturer Postal Code32773
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameQS820 MANUAL BED
Generic NameBED, MANUAL
Product CodeFNJ
Date Received2015-09-08
Model NumberIH820
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINVACARE FLORIDA OPERATIONS
Manufacturer Address2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-09-08

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