MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-28 for CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M M1669A 989803145071 manufactured by Philips Medical Systems.
[181399303]
Unable to confirm serial number. A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[181399304]
The customer reported a failure of the ecg trunk cable. Patient involvement is unknown. There was no reported patient incident/injury.
Patient Sequence No: 1, Text Type: D, B5
[185480851]
A replacement order was initiated. The material was requested for failure analysis but to date no material has been returned. If material is returned the complaint will be reopened and further processed.
Patient Sequence No: 1, Text Type: N, H10
[185480852]
The customer reported a failure of the ecg trunk cable. The device was not in use on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2020-00632 |
| MDR Report Key | 9636551 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-16 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-01-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 |
| Manufacturer Contact | MR. ROBERT CORNING |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M |
| Generic Name | TRUNK CABLE |
| Product Code | DSA |
| Date Received | 2020-01-28 |
| Model Number | M1669A |
| Catalog Number | 989803145071 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-28 |