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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACORN STAIRLIFTS INC ACORN 180; STAIRWAY CHAIRLIFT
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ACORN STAIRLIFTS INC ACORN 180; STAIRWAY CHAIRLIFT Back to Search Results
Model Number ACORN 180 RH
Device Problems Material Fragmentation (1261); Device Operates Differently Than Expected (2913); Inadequate User Interface (2958)
Patient Problem Abrasion (1689)
Event Date 08/22/2014
Event Type  malfunction  
Event Description
Client was dismounting lift at top landing by scooting to the front of the seat rather than swiveling the seat.In doing so the seat pad ripped from the base and client fell on the landing.Left arm was scraped.
 
Manufacturer Narrative
The root cause of the incident was that the fasteners had become fatigued by the users scooting motion.Mfr's instructions are to swivel the seat at the top.The seat was damaged beyond repair and was replaced.
 
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Brand Name
ACORN 180
Type of Device
STAIRWAY CHAIRLIFT
Manufacturer (Section D)
ACORN STAIRLIFTS INC
orlando FL
Manufacturer Contact
tracu berp
7335 lake ellenor drive
orlando, FL 32809
4076500216
MDR Report Key4602993
MDR Text Key5698629
Report Number3003124453-2015-00006
Device Sequence Number1
Product Code PCD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Not Applicable
Remedial Action Replace
Type of Report Initial
Report Date 03/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberACORN 180 RH
Was Device Available for Evaluation? No
Date Returned to Manufacturer08/23/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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