FDA Adverse Event
Malfunction
Summary report: N
FL-601-97B FAST LOC
MDR report key: 919636
·
Received September 25, 2007
Report
- Report Number
- 1056553-2007-00003
- Event Type
- Malfunction
- Date Received
- September 25, 2007
- Date of Event
- August 13, 2007
- Report Date
- September 24, 2007
- Manufacturer
- REMINGTON MEDICAL, INC.
- Product Code
- DSA
- PMA / PMN Number
- K9404967
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DISPOSABLE EXTENSION CABLES MANUFACTURED BY REMINGTON MEDICAL ARE SUBJECTED TO A 100% FINAL INSPECTION FOR DIELECTRIC AND CONTINUITY CRITERIA THAT MEETS OR EXCEEDS THE REQUIREMENTS. MANUFACTURING RECORDS INDICATE THE CABLE PASSED BOTH ELECTRICAL TESTS. THERE HAS NOT BEEN OTHER REPORTS OF THIS NATURE IN RELATION TO THE MANUFACTURING LOT NUMBER IN ADDITION REMINGTON MEDICAL HAS NOT RECEIVED ANY OTHER RELATED REPORTS.
Description of Event or Problem · 1
INSUFFICIENT SOLDER APPLIED DURING THE ASSEMBLY OF THE DEVICE, THUS RESULTING THE CABLE WIRE TO DETACH FROM THE CONNECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FL-601-97B FAST LOC | DISPOSABLE EXTENSION CABLE | DSA | REMINGTON MEDICAL, INC. | FL-601-97B | 0624410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Life Threatening |