FDA Adverse Event
Malfunction
Summary report: N
ANALYZER CABLE
MDR report key: 2790874
·
Received October 15, 2012
Report
- Report Number
- 2182208-2012-03263
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- July 17, 2012
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- KRG
- PMA / PMN Number
- P890003/S065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. PIECE OF CABLE INSULATION IS MISSING APPROXIMATELY 55 INCHES FROM THE ALLIGATOR CLIPS; CAN SEE OVER AN INCH OF INNER SHIELDING. NO ANOMALIES FOUND ON THE ALLIGATOR CLIP CONNECTIONS AND ANALYZER PLUG.
Description of Event or Problem · 1
IT WAS REPORTED THE ANALYZER CABLE WAS DAMAGED. THE CABLE IS BEING RETURNED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANALYZER CABLE | INSTRUMENT CABLE | KRG | MEDTRONIC, INC. | 2292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |