FDA Adverse Event
Malfunction
Summary report: N
HANDICARE ACCESSIBILITY LTD.
MDR report key: 22752524
·
Received August 8, 2025
Report
- Report Number
- 3011268530-2025-00003
- Event Type
- Malfunction
- Date Received
- August 8, 2025
- Date of Event
- June 23, 2025
- Report Date
- August 5, 2025
- Manufacturer
- HANDICARE ACCESIBILITY LTD.
- Product Code
- PCD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
RAIL FOUND TO HAVE SHEARED AT WELD JOIN. MINIMAL CHANCE OF FAILURE OCCURRING WITH PREVIOUS WELDING ((B)(4)), HOWEVER CHANGES TO PROCESS BETWEEN TIG & MIG WELDING OCCURRED AS AN IMPROVEMENT IN 2022. IMPLEMENTATION OF LOAD TESTING AT START AND END OF SHIFT FOR VALIDATION OF WELD PROCESS.
Description of Event or Problem · 0
TECH REPORTED THAT THE END USER TRIPPED OUT OF THE LIFT. HOWEVER, THEY WERE NOT INJURED AS SUPPORTED THEMSELVES AGAINST THE WALL. TECH COMMENTED THAT A LIFT RAIL CONNECTION APPEARED OPEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223487 | HANDICARE ACCESSIBILITY LTD. | STAIRLIFT | PCD | HANDICARE ACCESIBILITY LTD. | 2000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |