MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-07 for INVACARE RELIANT 450 BATTERY-POWERED LIFT RPL450-1 manufactured by Invacare Taylor Street.
[99330921]
The dealer provided a photograph of the electric actuator. The photograph shows that the mounting holes on the shaft extension of the actuator are worn through, which would result in the actuator becoming detached from the boom at the mounting bracket, as described. The lift was returned to invacare for an evaluation, and it was identified that the bushing, as well as the finger guard, were missing from the actuator assembly. This likely caused excessive play in the actuator end, that over time caused wear and lead to the actuator end breaking. It has been determined that the cause of the failure in aging devices (outside of their 8-year life expectancy, as is the case for this lift) is likely due to improper maintenance and/or placement of the bushing during initial assembly/maintenance by the purchaser of the lift. If the bushing is not in place then the metal-to-metal contact, between the shaft extension of the actuator and the shoulder bolt, will cause wear after considerable use. Review of current packaging confirmed that the bushing is assembled onto the shoulder bolt/nut on the lift boom when shipped from invacare's manufacturing site. The maintenance safety inspection checklist within the lift owner's manual instructs to inspect the hardware connecting the actuator assembly to the mast and boom and to check for wear or deterioration on a monthly basis. Any defective parts should be replaced immediately.
Patient Sequence No: 1, Text Type: N, H10
[99330922]
The dealer reported that her customer alleged that two certified nursing assistants were transferring the patient from a bed to a chair, and the rpl450-1 lift failed causing the patient to fall. The patient was sore following the incident but did not require any medical intervention. The facility indicated that the failure occurred where the actuator attaches to the boom of the lift; the bolt fell out and now the boom will not hold in a vertical position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2018-00013 |
| MDR Report Key | 7248218 |
| Date Received | 2018-02-07 |
| Date of Report | 2018-01-08 |
| Date Mfgr Received | 2018-01-08 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2018-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON FIEST |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA 44035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44035 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INVACARE RELIANT 450 BATTERY-POWERED LIFT |
| Generic Name | LIFT, PATIENT, AC-POWERED |
| Product Code | FNG |
| Date Received | 2018-02-07 |
| Returned To Mfg | 2018-01-24 |
| Model Number | RPL450-1 |
| Catalog Number | RPL450-1 |
| Operator | NURSING ASSISTANT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-07 |