MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-24 for AMC LW-341DS30/5A manufactured by Amc.
[121516292]
When opening a set of disposable cardiac monitor cables, it was noted that one of the cable wires was exposed out of the covering for about 18 inches. Checked stock in unit and no other packages with the same lot# had defects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7901530 |
| MDR Report Key | 7901530 |
| Date Received | 2018-09-24 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-09-11 |
| Report Date | 2018-09-13 |
| Date Reported to FDA | 2018-09-13 |
| Date Reported to Mfgr | 2018-09-24 |
| Date Added to Maude | 2018-09-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | AMC |
| Generic Name | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Product Code | DSA |
| Date Received | 2018-09-24 |
| Model Number | LW-341DS30/5A |
| Lot Number | 170605 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMC |
| Manufacturer Address | 11711 NW 39TH ST CORAL SPRINGS FL 33065 US 33065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-24 |