MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2015-04-02 for HOYER POWER LIFT WITH SCALE HPL402 manufactured by Apex Healthcare Mfg Inc.
[20457491]
It was reported to the manufacturer by the end user, per the end user the patient was being transferred from the portable commode to the hospital bed and the main bolt came out of the lift. The patient dropped to the floor and landed on his buttocks. The patient sustained the following injuries: bruising to the buttocks, right hand and scrotum area; swelling to the right hand and buttocks; skin tears and bleeding on the buttocks. The caregiver performed an assessment on the patient and contacted the nurse to come to the residence to evaluate the patient. Due to the patients condition, he was unable to leave the residence to receive medical attention. Hospice arranged for a mobile x-ray unit to go to the residence and perform x-rays as part of the evaluation. Complaint# (b)(4). Were entered into our system to have the lift and scale returned to joerns for investigation. As of the writing, the lift and scale has not been returned.
Patient Sequence No: 1, Text Type: D, B5
[20532955]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009402404-2015-00009 |
| MDR Report Key | 4681753 |
| Report Source | 04 |
| Date Received | 2015-04-02 |
| Date of Report | 2015-04-01 |
| Date of Event | 2015-03-03 |
| Date Facility Aware | 2015-03-03 |
| Report Date | 2015-04-01 |
| Date Reported to FDA | 2015-04-01 |
| Date Reported to Mfgr | 2015-04-01 |
| Date Mfgr Received | 2015-03-03 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-04-13 |
| 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 760140000 |
| Manufacturer Country | US |
| Manufacturer Postal | 760140000 |
| Manufacturer Phone | 8008260270 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER POWER LIFT WITH SCALE |
| Generic Name | ELECTRIC PATIENT LIFT |
| Product Code | FNG |
| Date Received | 2015-04-02 |
| Model Number | HPL402 |
| Catalog Number | HPL402 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 12 MO |
| 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 | 2015-04-02 |