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 - SMALL M1520A manufactured by Philips Medical Systems.
[69758988]
Patient Sequence No: 1, Text Type: N, H10
[69758989]
The patient peeled off the outer coating of the ecg monitor cord. Pieces of the device were found, we are unsure if the patient ingested any of the pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6398568 |
| MDR Report Key | 6398568 |
| Date Received | 2017-03-13 |
| Date of Report | 2017-02-17 |
| Date of Event | 2017-02-20 |
| 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 - SMALL |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-03-13 |
| Model Number | M1520A |
| ID Number | 989803103941 |
| 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 |