MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-28 for LWM-341DS30/5A manufactured by Amc.
[87639302]
Patient Sequence No: 1, Text Type: N, H10
[87639303]
When disposable leads were removed from manufacturer packaging and leads separated to attach to patient, the plastic housing peeled off of la lead exposing wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6900752 |
| MDR Report Key | 6900752 |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-07-05 |
| Report Date | 2017-09-07 |
| Date Reported to FDA | 2017-09-07 |
| Date Reported to Mfgr | 2017-09-07 |
| Date Added to Maude | 2017-09-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Product Code | DSA |
| Date Received | 2017-09-28 |
| Catalog Number | LWM-341DS30/5A |
| Lot Number | 170605 |
| ID Number | 5 LD GRPD DISPOSABLE GE MULTI |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMC |
| Manufacturer Address | 11711 NW 39TH STREET CORAL SPRINGS FL 33065 US 33065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-28 |