MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2020-03-27 for MEDI-TRACE# CADENCE ADULT RTS ZOLL 22770R manufactured by Covidien.
[187558462]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[187558523]
The customer reported that the defibrillation patches were applied anterior/posterior to chest and back and connected to a defibrillator, after the initial shock of 150 joules and unsuccessful cardioversion the staff noticed a faint burning smell and heard a pop. The pad placement and adherence were checked and agree to be correctly placed and adhered. The second shock was delivered at 200 joules, cardioversion was successful with similar result of burning smell. After the pads were removed the patient was found to have small burn marks on mid-chest but none on the back. The prominent burn mark was approximately 4 cm long with several smaller marks scattered where the edge of the pad had been. Silvadine was applied to the area per physician's order.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219103-2020-00278 |
| MDR Report Key | 9891812 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086172514 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2 LUDLOW PARKWAY |
| Manufacturer City | CHICOPEE MA 01022 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDI-TRACE# CADENCE ADULT RTS ZOLL |
| Generic Name | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
| Product Code | DRO |
| Date Received | 2020-03-27 |
| Model Number | 22770R |
| Catalog Number | 22770R |
| Lot Number | 934328X |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2 LUDLOW PARKWAY CHICOPEE MA 01022 US 01022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |