MAUDE Adverse Event Report: HANDICARE USA, INC. P-440 PATIENT LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number P-440

Device Problems Product Quality Problem (1506); Defective Component (2292)

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

Event Date 11/07/2022

Event Type  malfunction  

Event Description

I purchased a handicare p-440 patient ceiling lift from (b)(6).Immediately upon use the remote did not work correctly.The buttons on the unit itself works fine however, the remote did not.I immediately saw this as a product quality issue and asked to return it.I was told that this type of product was not eligible for return according to rehabmart.Com's return policy.I also had to deal with (b)(6) directly in coordinating some sort of resolution.Handicare itself would not give me any information and pointed to be back to rehabmart.Com.Long story short, after many emails and trying to contact supposed handicare authorized technicians, who never called me back, handicare sent me a new remote control.This remote also immediately did not work correctly.After contacting rehabmart.Com again about the issue, i eventually was sent a brand new unit from handicare.This product had the exact same issues.This seems to be an ongoing quality issue.There is a rating left by another consumer on (b)(6) website that explains that they too had the very same issue with this unit.That rating was left in (b)(6) 2021.They are charging people (b)(6) for these things with obvious quality issues.

• Brand Name: P-440 PATIENT LIFT
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): HANDICARE USA, INC.
• MDR Report Key: 16323409
• MDR Text Key: 309160411
• Report Number: MW5114762
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P-440
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White