FDA Adverse Event
Malfunction
Summary report: N
C625 MANUAL PT W/QRS HOOK ASSY
MDR report key: 3899287
·
Received May 30, 2014
Report
- Report Number
- 3007802293-2014-00014
- Event Type
- Malfunction
- Date Received
- May 30, 2014
- Date of Event
- April 22, 2014
- Report Date
- May 28, 2014
- Manufacturer
- PRISM MEDICAL
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL BULLETIN (TECHNICAL BULLETIN C-SERIES CHARGER ADAPTER BOARD 1-0008-2.PDF).
Description of Event or Problem · 1
CUSTOMER REPORTED THE CIRCUIT BOARD OF A C625 MANUAL PT BURNING. THE SYSTEM INVOLVES A TRANSITION GAGE, POWER TURNTABLE, AND MIDLINE CHARGER. THE LIFT WAS NOT OPERABLE AFTER THE INCIDENT AND WAS SERVICED BY OUR DEALER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320135 | C625 MANUAL PT W/QRS HOOK ASSY | C SERIES MANUAL POWER TURNTABLE | FSA | PRISM MEDICAL | 323846 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |