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 2019-01-23 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[133862798]
A follow-up report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[133862799]
The customer reported that the spiral tip of the fetal spiral electrode (989803137631) had broken. The baby required surgery to remove the tip and an overnight stay in the hospital.
Patient Sequence No: 1, Text Type: D, B5
[139912580]
It was reported that a baby girl/? Patient? Was born via? Normal birth? And the doctor used the device before the delivery time for monitoring of the fetal heart. Philips was advised that during the birth, the doctor had trouble connecting the device to the infant's head and after repeated attempts, the device had been replaced. At birth, the hospital reportedly saw swelling and redness that they assumed was caused by the repeated attempts to connect the device. Two weeks later, the patient appeared at the emergency room and a metallic foreign body attached to the scalp was noticed. The object was removed by surgery and the patient was hospitalized for one day for observation philips inquired if the difficulty in connecting the device could have resulted in the electrode being over rotated, leading to breakage of the device? S tip. The distributor responded that the doctor was unaware that the electrode broke, so he likely would not know how it broke. A return material authorization was issued for return of the device involved in the incident for evaluation. However, philips was advised that the hospital team was not aware of the occurrence of the broken electrode. Therefore, the device was not retained. Philips was also informed that the hospital does not have information about the device, batch or any other detail. Further information was requested related to this information, but an answer could not be provided. Philips is considering this a malfunction of cause unknown for reporting purposes only.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2019-00656 |
| MDR Report Key | 8270685 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-01-23 |
| Date of Report | 2019-01-20 |
| Date of Event | 2018-11-06 |
| Date Mfgr Received | 2019-01-20 |
| Date Added to Maude | 2019-01-23 |
| 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 | 2019-01-23 |
| Model Number | 989803137631 |
| Catalog 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 | 2019-01-23 |