MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-13 for 5 LEAD ECG PATIENT TRUNK CABLE SAFETY SET - LARGE manufactured by Philips Medical Systems.
[69758868]
Patient Sequence No: 1, Text Type: N, H10
[69758869]
The pt has a history of intentional ingestion. The patient was touching a cardiac monitoring wire. A portion of plastic shear to cord was noted to be missing with frayed wires exposed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6398553 |
| MDR Report Key | 6398553 |
| Date Received | 2017-03-13 |
| Date of Report | 2017-02-17 |
| Date of Event | 2017-01-31 |
| Report Date | 2017-02-17 |
| Date Reported to FDA | 2017-02-17 |
| Date Reported to Mfgr | 2017-02-17 |
| Date Added to Maude | 2017-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Brand Name | 5 LEAD ECG PATIENT TRUNK CABLE SAFETY SET - LARGE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-03-13 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-13 |