MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-02-26 for HOYER STATURE HOY-STATURE manufactured by Apex Healthcare Mfg Inc.
[5561157]
It was reported to the manufacturer by the facility (b)(6), per the facility 2 cna's were transferring a resident with the hoyer stature when it tipped over. The resident landed on one of the cna's and caused cna head to hit bedside table and floor. The other cna sustained injuries to her leg when she also fell. Both cna's were sent to the urgent care clinic. The cna's have hematoma on head and leg as well as swelling to the head, shoulder and leg. A joerns representative visited the facility on (b)(6) 2015. The lift and sling were evaluated. The casters on the lift were "sticking", making it more difficult to move the lift. The facility ordered new casters for all their lifts. During the incident, training provided by joerns rep. It was admitted that the cna put her foot on the leg of the lift and pulled the resident back into the chair by pulling on the sling. This caused the lift to tip over onto the cna's. It was also mentioned that the staff had tipped the lift in the past, but it did not go all the way over and was not reported to management until this incident when the lift went all the way over. Complaint # (b)(4) was entered into our system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2015-00005 |
| MDR Report Key | 4577973 |
| Report Source | 06 |
| Date Received | 2015-02-26 |
| Date of Report | 2015-02-27 |
| Date of Event | 2015-02-09 |
| Date Facility Aware | 2015-02-09 |
| Report Date | 2015-02-24 |
| Date Reported to FDA | 2015-02-24 |
| Date Reported to Mfgr | 2015-02-24 |
| Date Mfgr Received | 2015-02-09 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2015-03-09 |
| 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 | 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 STATURE |
| Generic Name | SIT TO STAND LIFT |
| Product Code | FNG |
| Date Received | 2015-02-26 |
| Model Number | HOY-STATURE |
| Catalog Number | HOY-STATURE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 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 | 2015-02-26 |