FDA Adverse Event
Malfunction
Summary report: N
POWER CORD 110V
MDR report key: 12908674
·
Received December 1, 2021
Report
- Report Number
- 3004936110-2021-00732
- Event Type
- Malfunction
- Date Received
- December 1, 2021
- Date of Event
- November 18, 2021
- Report Date
- February 22, 2022
- Manufacturer
- ST. JUDE MEDICAL, INC.
- Product Code
- MOM
- PMA / PMN Number
- P100045
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ONE PATIENT ELECTRONICS UNIT (PEU) MODEL # CM1100/ SERIAL # (B)(6) WITH ACCESSORIES WAS RECEIVED FOR EVALUATION. PHYSICAL DAMAGE WAS NOTED TO THE 12 VOLT DC SIDE OF THE POWER SUPPLY. THE RETURNED UNIT PASSED SOFTWARE EVALUATION. THE PEU WAS PLUGGED IN AND POWERED ON SUCCESSFULLY WITH A KNOWN GOOD TESTING UNIT. DIAGNOSTIC TESTING WAS PERFORMED AND CONFIRMED THE UNIT PASSED. THE REPORTED COMPLAINT WAS CONFIRMED; HOWEVER, THE CAUSE OF THE EVENT REMAINS UNKNOWN.
Description of Event or Problem · 0
CUSTOMER REPORTED THAT THE POWER CORD SPARKED. THE UNIT WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1807932 | POWER CORD 110V | SYSTEM, HEMODYNAMIC, IMPLANTABLE | MOM | ST. JUDE MEDICAL, INC. | CM3020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female |