FDA Adverse Event
Malfunction
Summary report: N
POWER CORD 110V
MDR report key: 22012056
·
Received May 13, 2025
Report
- Report Number
- 3004936110-2025-01000
- Event Type
- Malfunction
- Date Received
- May 13, 2025
- Date of Event
- May 12, 2025
- Report Date
- July 9, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- MOM
- PMA / PMN Number
- P100045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 CORD AND ONE POWER SUPPLY WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE POWER CORD WAS FRAYED, AND WIRES WERE EXPOSED. A TEST UNIT WAS ABLE TO POWER ON BY EXCHANGING THE DAMAGED POWER CORD WITH A GOLDEN CORD WHILE USING THE RETURNED POWER SUPPLY.
Description of Event or Problem · 0
THE PATIENT REPORTED SMOKING AND SPARKING FROM THE POWER CORD. THE POWER CORD AND POWERS SUPPLY WERE REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2369122 | POWER CORD 110V | SYSTEM, HEMODYNAMIC, IMPLANTABLE | MOM | ABBOTT MEDICAL | CM3020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |