MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-02 for CBL 3 LEADSET, SNAP, IEC, ICU M1674A manufactured by Philips Medical Systems.
[69152304]
This is a supplemental report to report 1218950-2016-07550. The product number has been changed from 861290 to m1674a to reflect the "ecg lead set". This report was created to reflect the new fda registration number.
Patient Sequence No: 1, Text Type: N, H10
[69152305]
It was reported to philips that the lead wire was defective. We will consider this to be an inability to acquire leads ecg. The customer did not report any patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2017-00066 |
| MDR Report Key | 6371983 |
| Date Received | 2017-03-02 |
| Date of Report | 2016-11-04 |
| Date Mfgr Received | 2016-11-04 |
| Date Added to Maude | 2017-03-02 |
| 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 | HEWLETT-PACKARD STR.2 |
| Manufacturer City | BOEBLINGEN 71034 |
| Manufacturer Country | GM |
| Manufacturer Postal | 71034 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CBL 3 LEADSET, SNAP, IEC, ICU |
| Generic Name | LEAD SET |
| Product Code | DSA |
| Date Received | 2017-03-02 |
| Model Number | M1674A |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | HEWLETT-PACKARD STR.2 BOEBLINGEN 71034 GM 71034 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-02 |