MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-01 for CBL 3 LEADSET, SNAP, IEC, ICU M1674A manufactured by Philips Medical Systems.
[61500801]
A follow up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[61500802]
It was reported to philips that the lead wire was defective. We will consider this to be an inability to acquire leads ecg. There was no reported patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[68785946]
See report # 9610816-2017-00066.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2016-07550 |
| MDR Report Key | 6137713 |
| Date Received | 2016-12-01 |
| Date of Report | 2016-11-04 |
| Date Mfgr Received | 2016-11-04 |
| Device Manufacturer Date | 2016-05-25 |
| Date Added to Maude | 2016-12-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DENYSE MURPHY |
| 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 LEADSET, SNAP, IEC, ICU |
| Generic Name | LEAD SET |
| Product Code | DSA |
| Date Received | 2016-12-01 |
| Model Number | M1674A |
| 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 | 2016-12-01 |