FDA Adverse Event
Malfunction
Summary report: N
CADENCE ZOLL PRECONNECT
MDR report key: 3023351
·
Received February 28, 2013
Report
- Report Number
- 1219103-2013-00003
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Report Date
- January 29, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MLN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 AN ELECTRODE. THE CUSTOMER REPORTS THIS ELECTRODE IS NOT RECOGNIZING THEIR QRS AND CANNOT DO SYNCHRONIZED CARDIO-VERSIONS. THE CUSTOMER FURTHER REPORTS THE FIRST SET OF PADS HAD NO ENERGY DELIVERED TO THE PT. THEY WERE REMOVED AND REPLACED WITH ANOTHER SET, AND THE SECOND SET DID HAVE ENERGY DELIVER TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88518 | CADENCE ZOLL PRECONNECT | ELECTRODES | MLN | COVIDIEN | 22770PC | 234250X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |