MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-09 for HOYER PRESENCE HOY-PRESENCEWSC manufactured by Apex Healthcare Mfg Inc.
[182697468]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182697469]
It was reported to the manufacturer by the end user, per the end user, per the recreation of the incident, staff placed blue non-hoyer brand sling under resident. Upon connection, staff did not note anything wrong. When lift began to rise, it was stated that as cradle turned the sling moved off of hook. It was speculated that since black disk was not in proper location, that the strap was able to slide off hook. As a result, the resident fell to floor and sustained multiple injuries. Complaint# (b)(4) and ra# (b)(4) were entered into our system to have the lift returned to joerns for investigation. As of this writing, the lift has not been returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2020-00020 |
| MDR Report Key | 9808238 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-01 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-09 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ARLINGTON, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 8260270331 |
| Manufacturer G1 | APEX HEALTHCARE MFG INC |
| Manufacturer Street | NO.6, INDUSTRIAL 2ND ROAD TOU CHIAO INDUSTRIAL PARK |
| Manufacturer City | MIN HSIUNG SHIANG, CHAI YI HSIEN |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HOYER PRESENCE |
| Generic Name | PATIENT LIFT |
| Product Code | FSA |
| Date Received | 2020-03-09 |
| Model Number | HOY-PRESENCEWSC |
| Catalog Number | HOY-PRESENCEWSC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APEX HEALTHCARE MFG INC |
| Manufacturer Address | NO.6, INDUSTRIAL 2ND ROAD TOU CHIAO INDUSTRIAL PARK MIN HSIUNG SHIANG, CHAI YI HSIEN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-09 |