MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for MEDI-TRACE CADENCE (17)211211 manufactured by Covidien/cardinal Health 200, Llc.
[180718825]
Scheduled cardioversion. Covidien adult multi-function defibrillation patches were applied anterior/posterior to chest and back and connected to zoll defibrillator, after initial shock o f150 joules and unsuccessful cardioversion, staff noticed a faint burning smell and heard a pop. Pad placement and adherence were checked and agrees to be correctly placed and adhered. Second shock was delivered at 200 joules (cardioversion successful) with similar result of burning smell. After pads were removed, patient was found to have small burn marks on mid chest, none on the back. The prominent burn mark was approx. 4 cm long. With several smaller marks scattered where the edge of the pad had been. Silvadene applied to area per physician order. Fda safety report # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093119 |
| MDR Report Key | 9733423 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-13 |
| Date Added to Maude | 2020-02-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | MEDI-TRACE CADENCE |
| Generic Name | PACEMARKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON- INVASIVE) |
| Product Code | DRO |
| Date Received | 2020-02-19 |
| Catalog Number | (17)211211 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN/CARDINAL HEALTH 200, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |