MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[127131543]
A follow up report will be submitted once the investigation is complete. Patient information requested not available at time of report. Serial number not available at time of report. Phone number (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[127131544]
The customer reported that the spiral tip of the fetal spiral electrode had broken. The patient was transferred to the rch for follow-up with a neurosurgeon about removing the coil.
Patient Sequence No: 1, Text Type: D, B5
[129511750]
An evaluation couldn? T be performed as the material involved in the incident was reported to be discarded. Philips considers this as a malfunction of unknown cause as the reported material couldn? T be evaluated,we are considering that, if the customer required new electrodes that they have purchased some.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-08925 |
| MDR Report Key | 8067007 |
| Date Received | 2018-11-13 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-11-02 |
| Date Mfgr Received | 2018-11-06 |
| Date Added to Maude | 2018-11-13 |
| 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. BETTY HARRIS |
| 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 | 0 |
| Brand Name | FETAL SPIRAL ELECTRODE |
| Generic Name | FETAL SPIRAL ELECTRODE, SINGLE |
| Product Code | HGP |
| Date Received | 2018-11-13 |
| Model Number | 989803137631 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2018-11-13 |