FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON ELITE MICROCOAGULATION SYSTEM
MDR report key: 2052057
·
Received March 2, 2011
Report
- Report Number
- 2248721-2011-00030
- Event Type
- Malfunction
- Date Received
- March 2, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 4, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JPA
- PMA / PMN Number
- K050016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD/RESULT/CONCLUSION: MFR/EVAL/INVESTIGATION CURRENTLY IN PROCESS. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem · 1
CUSTOMER REPORTS HEMOCHRON ELITE MICROCOAGULATION SYSTEM WAS USED BY AN EMPLOYEE AND HE RECEIVED AN ELECTRICAL SHOCK. THE ANALYST WAS TRANSFERRING FILES FROM THE DEVICE AND HIT THE START BUTTON. EVERY TIME HE PICKED UP THE DEVICE HE WOULD GET A SMALL SHOCK AND THEN EXPERIENCED A STRONGER SHOCK AND THE INSTRUMENT LOST POWER. NO MEDICAL TREATMENT WAS ADMINISTERED. NO REPORT OF SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON ELITE MICROCOAGULATION SYSTEM | JPA | INTERNATIONAL TECHNIDYNE CORP. | ELITE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |