MAUDE Adverse Event Report: EZ WAY, INC. 500LB SMART STAND WITH SCALE; STAND AID

Model Number S500PS

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

The facility attempted to repair the unit by welding it.This action prevents a proper analysis of the original weld condition.Section d8 - third party service conducted by ge healthcare as listed in section b5.Section h6 - no report of injury to the resident was reported by the facility for this incident.

Event Description

Customer reported that the, "nursing staff were transferring patient from her bed to chair with the lift.Patient was attached to the lift via the straps and sling.Lift arm broke and patient fell on the floor landing on her buttocks.Straps remained attached so the patient remained sitting upright on the floor." customer reported their maintenance staff follows a monthly inspection schedule for the unit involved in the incident.A maintenance record provided by the customer does not list the serial number of the unit identified in the incident.The maintenance records provided by the customer show the last inspection was completed on 03-aug-2023.Prior inspection records were provided by the customer dated (b)(6) 2023 and (b)(6) 2023 showing inspections were completed, these records do not list the identified unit involved in the incident.Instructions included in the inspection list, #3 raise and lower a test load while load is attached to stand.Check all structural welds for signs of stress or cracking.If found, remove lift from service until repairs have been completed." weight of the load to test the unit is not listed.Customer reported unit inspections are also performed by ge healthcare.The maintenance recorded from the ge healthcare inspection show the last inspection for this unit was completed on 03-aug-2023.Checklist details lists: check mechanical integrity & condition: no unsafe, damaged, defective, missing parts, & more.Section is rated as pass.

• Brand Name: 500LB SMART STAND WITH SCALE
• Type of Device: STAND AID
• Manufacturer (Section D): EZ WAY, INC.; 710 east main st.; clarinda IA 51632
• Manufacturer (Section G): EZ WAY, INC.; 710 east main street; clarinda IA 51632
• Manufacturer Contact: aaron davidshofer ; 710 east main street; clarinda, IA 51632 ; 7125421939
• MDR Report Key: 17751058
• MDR Text Key: 323515501
• Report Number: 2183887-2023-00004
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S500PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 133 KG