MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-12 for INTELLIVUE M1669A ECG TRUNK CABLE manufactured by Philips Medical Systems.
[94502963]
Patient Sequence No: 1, Text Type: N, H10
[94502964]
While inspecting the bedside monitors, the clinician noted excessive deterioration of the ecg trunk cable near the ecg lead connection point. Rn noted that the insulating cover was "melting" and separation of the connector body covering. Biomedical contacted and also confirmed that the connector body was being dissolved by some cleaning agent. Biomedical inspected additional ecg trunk cables and noted the same plastic breakdown occurring. Biomedical contacted evs and the manufacturer for advise on cleaning agents allowed. Biomedical substituted with an alternative ecg trunk cable that could be used without deteriorating effects until cleaning issue/substance resolved. Manufacturer response for cable, ecg, trunk, 3-lead, intellivue (per site reporter). Awaiting manufacturer feedback.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7107648 |
| MDR Report Key | 7107648 |
| Date Received | 2017-12-12 |
| Date of Report | 2017-12-02 |
| Date of Event | 2017-11-15 |
| Report Date | 2017-12-02 |
| Date Reported to FDA | 2017-12-02 |
| Date Reported to Mfgr | 2017-12-02 |
| Date Added to Maude | 2017-12-12 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | INTELLIVUE M1669A ECG TRUNK CABLE |
| Generic Name | CABLE, ELECTRODE |
| Product Code | IKD |
| Date Received | 2017-12-12 |
| Model Number | M1669A |
| Catalog Number | M1669A |
| ID Number | 989803145071 |
| Operator | NURSE |
| 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 ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-12 |