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 2018-08-03 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[115942377]
Serial number unknown. Follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[115942378]
The customer reported that the spiral tip of the fetal spiral electrode (b)(4) had broken. The tip of the electrode was removed from the baby's scalp.
Patient Sequence No: 1, Text Type: D, B5
[125375363]
The customer reported the tip of (b)(4) fetal spiral electrode broke and remained in the baby's scalp. During the cesarean birth, the fetal spiral electrode could not be removed, so the wires were cut. After the birth, the remaining tip of the fetal spiral electrode was removed. A product return was requested, but no product was returned for evaluation. Therefore, the reported problem could not be confirmed. It is possible that the electrode was over-rotated, but this cannot be confirmed due to no product return. A refresher training session has been offered to the hospital staff.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-06171 |
| MDR Report Key | 7747416 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-08-03 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-07-18 |
| Date Mfgr Received | 2018-07-25 |
| Date Added to Maude | 2018-08-03 |
| 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 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 | 2018-08-03 |
| Model Number | 989803137631 |
| Lot Number | 180524 |
| Device Availability | Y |
| 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 | 2018-08-03 |