MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2020-01-14 for RELIANT 450 POWER LOW BASE LIFT 9153646735 NA:RPL450-2 RPL450-2 manufactured by Invamex Manufacturing.
[189037252]
Based on the information provided, the complaint could not be verified, and a device malfunction cannot be confirmed. The underlying cause of the boom dropping could not be determined. A return of the lift was requested, however, the facility will not return it, therefore, it is not known if the lift malfunctioned, or if it was user error that caused the mast to fall. This event has not been determined to be the result of a device malfunction. This lift was manufactured by (b)(4). However, they are no longer in business. The manufacturer of these lifts has since been transitioned to invamex. Therefore, the mdr is being filed under invamex.
Patient Sequence No: 1, Text Type: N, H10
[189037253]
The facility was using an rpl450-2 lift to get the resident out of bed. They had her over a wheelchair when the mast went down without them trying to lower it. The resident fell down into the chair and the mast hit her in the forehead. The patient went to the er, where she received 3 stitches in her head, and was released. The product has been taken out of use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616091-2020-00005 |
| MDR Report Key | 9587802 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2020-01-14 |
| Date of Report | 2018-07-19 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2020-01-14 |
| 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 MANUFACTURING |
| Manufacturer Street | 102 PARQUE INDUSTRIAL MANIMEX |
| Manufacturer City | REYNOSA, TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIANT 450 POWER LOW BASE LIFT 9153646735 |
| Generic Name | LIFT, PATIENT, AC-POWERED |
| Product Code | FNG |
| Date Received | 2020-01-14 |
| Model Number | NA:RPL450-2 |
| Catalog Number | RPL450-2 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVAMEX MANUFACTURING |
| Manufacturer Address | 102 PARQUE INDUSTRIAL MANIMEX REYNOSA, TAMAULIPAS 88780 MX 88780 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-14 |