Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDICARE 2000; STAIRLIFT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

HANDICARE 2000; STAIRLIFT Back to Search Results
Model Number 2000
Device Problems Installation-Related Problem (2965); Fail-Safe Did Not Operate (4046)
Patient Problems Bruise/Contusion (1754); Fall (1848)
Event Date 04/12/2019
Event Type  malfunction  
Event Description
The user fell out of the seat of the stairlift while travelling up the stairs.The lift didn't stop at the top of the stair case as it should, driving through the mechanical end-stop.The trunnion subsequently ran off the rail end causing the seat to tilt forward and the user to fall out of the seat.The user was not wearing the seatbelt and sustained bruising in the fall.The user did not sustain serious injuries.
 
Manufacturer Narrative
The mechanical end-stop had been modified by the installer when he was trying to install the lift.This prevented the end-stop from working as designed and stopping the lift at the top of the stairs.The installer has been retrained and all lifts he installed of this model were inspected and corrected to factory specification.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
2000
Type of Device
STAIRLIFT
Manufacturer (Section D)
HANDICARE
82 first avenue
pensnett estate
kingswinford, west midlands DY6 7 FJ
UK  DY6 7FJ
MDR Report Key8601566
MDR Text Key145656871
Report Number3011268530-2019-00018
Device Sequence Number1
Product Code PCD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Remedial Action Repair
Type of Report Initial,Followup
Report Date 10/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number2000
Device Catalogue NumberOCP
Was Device Available for Evaluation? No
Distributor Facility Aware Date04/12/2019
Device Age1 YR
Event Location Home
Date Manufacturer Received04/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-