ACORN 180 ACORN 180 LH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-02-27 for ACORN 180 ACORN 180 LH manufactured by Acorn Stairlifts, Inc..

Event Text Entries

[68442027] Inspected lift on site and could not duplicate any issue with the lift stopping mid rail. Tested successfully full runs up/ down multiple trips. All systems checks were normal and lift functioning to spec. All safety edges tested properly, no safety edges engaged. Client could not recall if she had possibly engaged the arm interlock switch while riding the lift up. Tech did another demo with the client to ensure proper education or swiveling and riding position with seat belt as well as arm interlock.
Patient Sequence No: 1, Text Type: N, H10


[68442028] Client was riding the lift upstairs late in the evening hours in complete darkness. The lift stopped mid lading she tried to get off she fell and broke 3 ribs. Client refused to provide any information regarding hospitalization or emergency care.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003124453-2017-22317
MDR Report Key6362221
Report SourceCONSUMER
Date Received2017-02-27
Date of Report2014-11-14
Date of Event2014-10-16
Date Mfgr Received2014-10-16
Device Manufacturer Date2014-07-01
Date Added to Maude2017-02-27
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 EDNA LOPEZ
Manufacturer Street7001 LAKE ELLENOR DIRVE
Manufacturer CityORLANDO FL 32809
Manufacturer CountryUS
Manufacturer Postal32809
Manufacturer Phone4076500216
Manufacturer G1ACORN STAIRLIFTS, INC.
Manufacturer Street7001 LAKE ELLENOR DRIVE
Manufacturer CityORLANDO FL 32822
Manufacturer CountryUS
Manufacturer Postal Code32822
Single Use3
Remedial ActionIN
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACORN 180
Generic NameSTAIRWAY CHAIRLIFT
Product CodePCD
Date Received2017-02-27
Model NumberACORN 180 LH
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerACORN STAIRLIFTS, INC.
Manufacturer Address7001 LAKE ELLENOR DRIVE ORLANDO FL 32809 US 32809


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-02-27

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