MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-08-09 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[116559951]
A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[116559952]
The customer reported that the spiral tip of the fetal spiral electrode (989803137631) had broken. The tip of the 989803137631 fetal spiral electrode was removed from the baby's scalp.
Patient Sequence No: 1, Text Type: D, B5
[125978652]
The product was returned for evaluation. After inspecting the material under a microscope, it is possible that the electrode was over-rotated. Microscopic inspection of the material showed no defects in the metal.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-06255 |
| MDR Report Key | 7767507 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-08-09 |
| Date of Report | 2018-08-07 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-08-07 |
| Date Added to Maude | 2018-08-09 |
| 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 | 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 | FETAL SPIRAL ELECTRODE |
| Generic Name | FETAL SPIRAL ELECTRODE, SINGLE |
| Product Code | HGP |
| Date Received | 2018-08-09 |
| Returned To Mfg | 2018-10-01 |
| Model Number | 989803137631 |
| Lot Number | 171624 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-08-09 |