MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-27 for MEDI-TRACE CADENCE manufactured by Covidien.
[68774448]
No shock delivery when pt in vf (arrested). When hitting the shock button, no shock given. After several attempts, switched electrodes/leads and were able to deliver shock. When inspecting the product, it looked there was a defect. We have experienced the same thing at least twice in the er.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068163 |
| MDR Report Key | 6363986 |
| Date Received | 2017-02-27 |
| Date of Report | 2017-02-27 |
| Date of Event | 2017-02-19 |
| Date Added to Maude | 2017-02-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDI-TRACE CADENCE |
| Generic Name | DEFIB ELECTRODES |
| Product Code | MLN |
| Date Received | 2017-02-27 |
| Lot Number | 617331X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD ME 02048 US 02048 |
| Brand Name | MEDI-TRACE CADENCE |
| Generic Name | DEFIB ELECTRODES |
| Product Code | GXY |
| Date Received | 2017-02-27 |
| Lot Number | 617331X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | MANSFIELD ME 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-02-27 |