MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-17 for POWER LIFT W/LOW BASE-PLUS 9153633519 RPL450-1 manufactured by Invamex.
[70240206]
The lift has not been returned for evaluation. The complaint could not be verified, and the underlying cause could not be determined. Based on the information provided, a device malfunction cannot be confirmed. The nursing home administrator stated that they did not notice if the locknut was loose prior to using the lift. The invacare reliant rpl450-1 user manual states, "after any adjustments, repair or service and before use, make sure all attaching hardware is tightened securely - otherwise injury or damage may occur. " additionally, the maintenance safety inspection checklist states to inspect/adjust monthly the boom: check all hardware and hanger bar supports, and the hanger bar: check the bolt/hooks for wear or damage. A replacement lift has been sent to the nursing home. Should additional information become available, a supplemental record will be filed.
Patient Sequence No: 1, Text Type: N, H10
[70240207]
The nursing home administrator stated that two assistants were transferring the patient from a bed to a chair when the locknut popped off the bolt that holds the hanger bar onto the boom assembly causing the hanger bar to fall off. The patient fell to the floor and sustained a broken nose and broken ribs. X-rays were performed and the patient was hospitalized; it is unknown for how long.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616091-2017-00002 |
| MDR Report Key | 6413150 |
| Report Source | USER FACILITY |
| Date Received | 2017-03-17 |
| Date of Report | 2017-02-15 |
| Date Mfgr Received | 2017-02-15 |
| Device Manufacturer Date | 2015-11-01 |
| Date Added to Maude | 2017-03-17 |
| 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 |
| 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 | INVAMEX |
| Manufacturer Street | 102 PARQUE INDUSTRIAL MANIMEX |
| Manufacturer City | REYNOSA, TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWER LIFT W/LOW BASE-PLUS 9153633519 |
| Generic Name | LIFT, PATIENT, AC-POWERED |
| Product Code | FNG |
| Date Received | 2017-03-17 |
| Model Number | RPL450-1 |
| Catalog Number | RPL450-1 |
| Operator | NURSING ASSISTANT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVAMEX |
| Manufacturer Address | 102 PARQUE INDUSTRIAL MANIMEX REYNOSA, TAMAULIPAS 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-03-17 |