FDA Adverse Event
Malfunction
Summary report: N
CADENCE PHYSIO QC ADULT RTS
MDR report key: 3071145
·
Received April 8, 2013
Report
- Report Number
- 1219103-2013-00014
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- April 2, 2013
- Report Date
- April 4, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MLN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2013 THAT A CUSTOMER HAD AN ISSUE WITH DEFIBRILLATION ELECTRODES. THE CUSTOMER REPORTS DURING A CARDIOVERSION AS THE SHOCK WAS BEING DELIVERED THE STAFF HEARD A "POP". THE CUSTOMER FURTHER REPORTS THERE WAS AN INSULATION BREAK ON ONE OF THE WIRES BY THE CONNECTOR. THE ELECTRODES WERE REPLACED WITH ANOTHER SET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144425 | CADENCE PHYSIO QC ADULT RTS | DEFIBRILLATION ELECTRODES | MLN | COVIDIEN | 22550R | 305320X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |