FDA Adverse Event
Malfunction
Summary report: N
PRESSURE FIT (2 POST) WITH SWIVEL TROLLEY
MDR report key: 6458690
·
Received April 4, 2017
Report
- Report Number
- 3007802293-2017-00088
- Event Type
- Malfunction
- Date Received
- April 4, 2017
- Date of Event
- February 26, 2017
- Report Date
- April 4, 2017
- Manufacturer
- PRISM MEDICAL
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
OUTCOME OF INVESTIGATION PENDING. A FINAL REPORT WILL BE SUBMITTED UPON COMPLETION.
Description of Event or Problem · 1
AN INDIVIDUAL WAS BEING HOISTED USING A PRESSURE FIT (2 POST) WITH SWIVEL TROLLEY FROM HER BED TO WHEEL CHAIR BY 2 CARER'S. WHILE BEING TRANSFERRED THE SWIVEL HOOK OPENED UP AND ROLL PIN CAME OUT. THE INDIVIDUAL FELL TO THE FLOOR ON THEIR BACK. THE HOIST THEN FOLLOWED AND LANDED ON THEIR STOMACH. PARAMEDICS WERE CALLED. THEY CHECKED THE INDIVIDUAL OVER. NO INJURIES WERE REPORTED. NO HOSPITAL VISIT WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240417 | PRESSURE FIT (2 POST) WITH SWIVEL TROLLEY | PRESSURE FIT WITH SWIVEL TROLLEY | FSA | PRISM MEDICAL | 341502 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |