FDA Adverse Event
Malfunction
Summary report: N
FGA 450 / 3-ALUMINUM LIFT 450 LB MEDIUM HEIGHT
MDR report key: 5011594
·
Received August 12, 2015
Report
- Report Number
- 3007802293-2015-00031
- Event Type
- Malfunction
- Date Received
- August 12, 2015
- Date of Event
- July 16, 2015
- Report Date
- August 11, 2015
- Manufacturer
- PRISM MEDICAL
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ITEM IS BEING SHIPPED BACK FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE LIFT HAS BEEN RECEIVED AND ANALYZED.
Description of Event or Problem · 1
FGA 450 LIFT WAS IDENTIFIED WITH A CRACKED WELD AT TIME OF PREVENTATIVE MAINTENANCE CHECK. NO PATIENT INVOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 529602 | FGA 450 / 3-ALUMINUM LIFT 450 LB MEDIUM HEIGHT | FGA450 / 3 | FSA | PRISM MEDICAL | 280410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |