FDA Adverse Event
Malfunction
Summary report: N
EXPRESS 4
MDR report key: 4092835
·
Received August 21, 2014
Report
- Report Number
- 2023446-2014-00133
- Event Type
- Malfunction
- Date Received
- August 21, 2014
- Date of Event
- February 19, 2014
- Report Date
- February 19, 2013
- Manufacturer
- IRIS INTERNATIONAL
- Product Code
- JQC
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- FA-14002
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IT WAS REPORTED THE POWER CONNECTOR TO MAIN CONTROL BOARD WAS BURNED ON THE EXPRESS 4 UNIT. THE STEADY WRENCH LIGHT ON THE UNIT WAS DUE TO THE UNIT REACHING 50,000 CYCLES. THERE WAS NO REPORTS OF INJURIES, OPEN FLAMES, SMOKE EMISSION, BURNT SMELL, OR FIRE DEPARTMENT BEING CALLED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE POWER HARNESS BURNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504575 | EXPRESS 4 | STATSPIN CENTRIFUGE | JQC | IRIS INTERNATIONAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |