MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-19 for INVACARE RELIANT 600 HEAVY-DUTY POWER LIFT WITH MANUAL LOW BASE RPL600-1 manufactured by Invamex.
[100399491]
There was no alleged defect or malfunction with the lift. The device was not being used at the time of the incident; it was left unattended in the facility's hallway. The facility advised that the patient is ambulatory, but they may not have the mental cognitive ability to understand that they should not walk into the lift. The product will not be returned to invacare for an evaluation. The facility maintenance director stated that they are not in possession of the hanger assembly, and they are not aware of its location. He indicated that it may have been disposed of by emergency services or the hospital. Should additional information become available, a supplemental record will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[100399492]
The maintenance director of a nursing facility reported that one of the facility's patients was walking through the hallway, where they allegedly walked into the rpl600-1 lift, and one of the hooks on the lift's hanger bar went through the patient's mouth area. Emergency services was called, and they transported the patient to the hospital. The patient remained in the hospital for at least 3 days; however, the specific injuries sustained are unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616091-2018-00005 |
| MDR Report Key | 7280538 |
| Date Received | 2018-02-19 |
| Date of Report | 2018-01-22 |
| Date of Event | 2018-01-19 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2018-02-19 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INVACARE RELIANT 600 HEAVY-DUTY POWER LIFT WITH MANUAL LOW BASE |
| Generic Name | LIFT, PATIENT, AC-POWERED |
| Product Code | FNG |
| Date Received | 2018-02-19 |
| Model Number | RPL600-1 |
| Catalog Number | RPL600-1 |
| Operator | DEVICE UNATTENDED |
| 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 | 2018-02-19 |