MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for 200 MEDI-TRACE 100/PK 1000/CA 31050522 manufactured by Covidien.
[131131179]
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Patient Sequence No: 1, Text Type: N, H10
[131131180]
The customer reported the patient was sweating and the electrodes came off. The machine alarmed as an unconnected electrode compromising the immediate identification of the cardiac arrhythmia/cardiopulmonary arrest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681860-2018-00502 |
| MDR Report Key | 8186497 |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-10-26 |
| Date Mfgr Received | 2018-12-03 |
| Date Added to Maude | 2018-12-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 215 HEBERT ST |
| Manufacturer City | GANANOQUE K7G 2Y7 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K7G 2Y7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 200 MEDI-TRACE 100/PK 1000/CA |
| Generic Name | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
| Product Code | MLN |
| Date Received | 2018-12-20 |
| Model Number | 31050522 |
| Catalog Number | 31050522 |
| Lot Number | 730678X |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 215 HEBERT ST GANANOQUE K7G 2Y7 CA K7G 2Y7 |
| Brand Name | 200 MEDI-TRACE 100/PK 1000/CA |
| Generic Name | PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) |
| Product Code | DRO |
| Date Received | 2018-12-20 |
| Model Number | 31050522 |
| Catalog Number | 31050522 |
| Lot Number | 730678X |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 215 HEBERT ST GANANOQUE K7G 2Y7 CA K7G 2Y7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-12-20 |