FDA Adverse Event
Malfunction
Summary report: N
POWER CORD 110V
MDR report key: 19772033
·
Received July 18, 2024
Report
- Report Number
- 3004936110-2024-00951
- Event Type
- Malfunction
- Date Received
- July 18, 2024
- Date of Event
- July 17, 2024
- Report Date
- October 3, 2024
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- MOM
- PMA / PMN Number
- P100045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.
Additional Manufacturer Narrative · 0
ONE POWER SUPPLY MODEL CM1110 AND ONE POWER CORD MODEL CM3020 WERE RECEIVED FOR EVALUATION. VISUAL EVALUATION REVEALED NO PHYSICAL DAMAGE OR DISCREPANCY TO EITHER CORD. THE REPORTED COMPLAINT OF EXPOSED WIRES AND SPARKING WAS NOT CONFIRMED.
Description of Event or Problem · 0
THE PATIENT REPORTED EXPOSED AND FRAYED WIRES OF THE POWER CORD WITH SPARKING. THE PATIENT ELECTRONIC UNIT WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1500178 | POWER CORD 110V | SYSTEM, HEMODYNAMIC, IMPLANTABLE | MOM | ST. JUDE MEDICAL, INC. | CM3020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Unknown |