MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-22 for HOYER PRESSURE LIFT HOY-PRESSURE manufactured by Apex Healthcare Mfg Inc.
[15842597]
It was reported to the mfr by the end user, per the end user the resident was being transferred from the bed to a chair using the lift. The lift was going in sideways, legs closed and brakes unlocked. One cna was operating the lift and the other cna was pulling the sling to properly position the resident in the chair. The lift tipped sideways in the opposite direction of the cna pulling the sling. The resident hit the wall hard and slid down the wall to land on the floor. The sling was unhooked from the lift and a nurse was called for assistance and to assess the pt. The resident was sent to the hosp for eval. She sustained a broken patella and was put into a leg brace. The resident has returned to the facility. The lift was inspected by facility maintenance and returned to service after the incident. The hoyer sling involved was returned to service as well. Proper lift and sling usage training was given by a joerns healthcare rep a few weeks prior to this incident. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16364968]
Joerns sending the report to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009402404-2015-00011 |
| MDR Report Key | 4734280 |
| Report Source | 06 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-21 |
| Date of Event | 2015-04-04 |
| Date Facility Aware | 2015-04-04 |
| Report Date | 2015-04-21 |
| Date Reported to FDA | 2015-04-21 |
| Date Reported to Mfgr | 2015-04-21 |
| Date Mfgr Received | 2015-04-14 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2015-04-29 |
| 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 | 0 |
| Manufacturer Contact | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN RD |
| Manufacturer City | ARLINGTON TX 76014 |
| Manufacturer Country | US |
| Manufacturer Postal | 76014 |
| Manufacturer Phone | 8008260270 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER PRESSURE LIFT |
| Generic Name | ELECTRIC PT LIFT |
| Product Code | FNG |
| Date Received | 2015-04-22 |
| Model Number | HOY-PRESSURE |
| Catalog Number | HOY-PRESSURE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APEX HEALTHCARE MFG INC |
| Manufacturer Address | MIN HSIUNG, CHI YI TW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2015-04-22 |