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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACORN STAIRLIFTS, INC. GENERIC 180 T565 LH US; POWER STAIRWAY CHAIR LIFT
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ACORN STAIRLIFTS, INC. GENERIC 180 T565 LH US; POWER STAIRWAY CHAIR LIFT Back to Search Results
Device Problems Misassembled (1398); Insufficient Information (3190); Misassembly During Maintenance/Repair (4054)
Patient Problem Bone Fracture(s) (1870)
Event Date 12/08/2019
Event Type  Injury  
Manufacturer Narrative
At this time, acorn is unable to determine the root cause because there is insufficient information regarding the customer incident.The customer is still in rehabilitation.Acorn has attempted to contact the customer for an interview and to perform another site visit but has been unsuccessful to date.On (b)(6) 2020 the customer's friend was contacted and informed acorn the customer would be home on (b)(6) 2020 at the earliest.Upon completion of a full investigation, acorn will send a follow-up report.
 
Event Description
On the evening of (b)(6) 2019, the customer called into acorn stairlifts, inc.(acorn) because her lift was inoperable.The customer had called in earlier that day requesting service because the stairlift was running slower than normal.A service visit was book for the following monday (b)(6) 2019.Sometime between when the customer called acorn on (b)(6) 2019 and when acorn arrived at the customer's home on (b)(6) 2019 the customer fell trying to use the stairs and was taken to the hospital.Acorn was not aware of the incident until (b)(6) 2020 when the customer's friend contacted acorn to schedule a service appointment to get the stairlift operational again in anticipation of the customer's return home.On (b)(6) 2020 an acorn service tech was in the customer's home and received confirmation from the customer's friend that the customer did fall down the stairs and fracture her neck and several ribs.
 
Manufacturer Narrative
After a regional manager inspected the stairlift on (b)(6) 2020, acorn determined improper datum set/ programming and not following proper servicing procedures when servicing the unit caused the stairlift to become inoperable.During the (b)(6) 2020 site visit the stairlift was reprogrammed and repaired back to operating specifications.
 
Event Description
On the evening of (b)(6) 2019, the customer called into acorn stairlifts, inc.(acorn) because her lift was inoperable.The customer had called in earlier that day requesting service because the stairlift was running slower than normal.A service visit was book for the following monday (b)(6) 2019.Sometime between when the customer called acorn on (b)(6) 2019 and when acorn arrived at the customer's home on (b)(6) 2019 the customer fell trying to use the stairs and was taken to the hospital.Acorn was not aware of the incident until (b)(6) 2020 when the customer's friend contacted acorn to schedule a service appointment to get the stairlift operational again in anticipation of the customer's return home.On (b)(6) 2020 an acorn service tech was in the customer's home and received confirmation from the customer's friend that the customer did fall down the stairs and fracture her neck and several ribs.
 
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Brand Name
GENERIC 180 T565 LH US
Type of Device
POWER STAIRWAY CHAIR LIFT
Manufacturer (Section D)
ACORN STAIRLIFTS, INC.
7001 lake ellenor drive
orlando, fl FL 32809
MDR Report Key9662578
MDR Text Key192069753
Report Number3003124453-2020-00003
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 consumer
Remedial Action Repair
Type of Report Initial,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Initial Date Manufacturer Received 01/04/2020
Initial Date FDA Received02/03/2020
Supplement Dates Manufacturer Received01/04/2020
Supplement Dates FDA Received03/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
WALKER; WALKER
Patient Outcome(s) Hospitalization;
Patient Age80 YR
Patient Weight48
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