FDA Adverse Event
Malfunction
Summary report: N
6 FOOT DISPOSABLE EXTENSION CABLE WITH SAFE CONNECT / SCREW-DOWN
MDR report key: 17595087
·
Received August 22, 2023
Report
- Report Number
- 17595087
- Event Type
- Malfunction
- Date Received
- August 22, 2023
- Date of Event
- May 8, 2024
- Report Date
- August 15, 2023
- Manufacturer
- REMINGTON MEDICAL, INC.
- Product Code
- DSA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- LA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
"CABLE PRONGS FAULTY." MANUFACTURER RESPONSE FOR PACING CABLE, REMINGTON (PER SITE REPORTER). THEY SENT US REPLACEMENT PRODUCT AND WILL INVESTIGATE WHEN THEY RECEIVE THE FAULTY ONE BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249289 | 6 FOOT DISPOSABLE EXTENSION CABLE WITH SAFE CONNECT / SCREW-DOWN | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | DSA | REMINGTON MEDICAL, INC. | FL-601-97 | 2230016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |