AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS IHCS9FX

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-08-04 for AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS IHCS9FX manufactured by Invacare Continuing Care.

Event Text Entries

[4634096] Dealer alleged that the frame is bent.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003433498-2014-00149
MDR Report Key3977288
Report Source08
Date Received2014-08-04
Date of Report2014-06-27
Date Mfgr Received2014-06-27
Date Added to Maude2014-08-14
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 FDA0
Event Location0
Manufacturer ContactGREGORY STEVENS
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1INVACARE CONTINUING CARE
Manufacturer Street994 HARGRIEVE ROAD
Manufacturer CityLONDON N6E1P5
Manufacturer CountryCA
Manufacturer Postal CodeN6E 1P5
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
Generic Name880.5100
Product CodeFNJ
Date Received2014-08-04
Model NumberIHCS9FX
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINVACARE CONTINUING CARE
Manufacturer Address994 HARGRIEVE ROAD LONDON N6E1P5 CA N6E 1P5


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-08-04

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