BED, MANUAL IHCS5

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 2014-08-26 for BED, MANUAL IHCS5 manufactured by Invacare Continuing Care.

Event Text Entries

[20779285] It was reported by the provider that the leg and link assembly is not working on ihcs5 bed to engage the brakes. No patient injury alleged, no additional information provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003433498-2014-00169
MDR Report Key4037801
Report Source08
Date Received2014-08-26
Date of Report2014-07-28
Date Mfgr Received2014-07-28
Date Added to Maude2014-09-09
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 ContactKAREN LOUGHREN
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1INVACARE CANADA
Manufacturer Street570 MATHESON BLVD E UNIT 8
Manufacturer CityMISSISSAUGA ON L4Z4G4
Manufacturer CountryCA
Manufacturer Postal CodeL4Z 4G4
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBED, MANUAL
Generic Name880.5120
Product CodeFNJ
Date Received2014-08-26
Model NumberIHCS5
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 2014-08-26

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