FDA Adverse Event
Injury
Summary report: N
JOERNS HEALTHCARE
MDR report key: 8561670
·
Received April 26, 2019
Report
- Report Number
- 8561670
- Event Type
- Injury
- Date Received
- April 26, 2019
- Date of Event
- April 22, 2019
- Report Date
- April 23, 2019
- Manufacturer
- JOERNS HEALTHCARE
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
RESIDENT WAS BEING TRANSFERRED FROM BED TO CHAIR. AS RESIDENT WAS ABOUT TO BE LOWERED TO THE CHAIR (JUST AS STAFF WAS ABOUT TO PRESS THE LOWER BUTTON ON THE REMOTE) THE MACHINE FAILED AND THE DEVICE COLLAPSED. NO NOISE WAS HEARD PRIOR TO THE BREAK/FAILURE. NO JOLTING OR DIFFICULTY OCCURRED DURING THE TRANSFER TO INDICATE A POTENTIAL PROBLEM. JOERNS CONTACTED AND INFORMED. PICTURES ALSO SUBMITTED. JOERNS REP WILL BE ONSITE ON 04/02/2019 TO INSPECT HOYER. ALL OTHER HOYERS WITHIN FACILITY INSPECTED IMMEDIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351186 | JOERNS HEALTHCARE | HOYER LIFT | FSA | JOERNS HEALTHCARE | HPL-402 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |