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 2018-08-31 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[118910658]
A follow up report will be submitted once the investigation is complete. Date of event is unknown and has been requested. Serial number not available at time of report.
Patient Sequence No: 1, Text Type: N, H10
[118910659]
The customer reported that the spiral tip of the fetal spiral electrode had broken. The tip of the fetal spiral electrode was removed from the baby's scalp.
Patient Sequence No: 1, Text Type: D, B5
[128859788]
The product was returned for evaluation. The used electrode spiral tip showed it been stretched out. Microscopic inspection of the material showed no defects in the metal. A quality support engineer also inspected the electrode and concluded the electrode had been pulled rather than rotated to remove it. The instructions for use (ifu) states for the user to? Turn the grip clockwise, typically one full turn using the protective tab as a visual guide. The ifu warns against over-rotating the spiral tip during attachment and pulling the spiral tip from the fetal skin. We are considering that if the customer required new electrodes, they have purchased some. Philips has not received any confirmation from the consumer about any injury or medical intervention that might have been performed. Without any further information, philips has not been able to determine if this was an adverse event involving injury.
Patient Sequence No: 1, Text Type: N, H10
[128859789]
The customer reported that the spiral tip of the fetal spiral electrode had had stretched out during the removal of the electrode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2018-07056 |
| MDR Report Key | 7837515 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-08-31 |
| Date of Report | 2018-08-30 |
| Date Mfgr Received | 2018-08-30 |
| Date Added to Maude | 2018-08-31 |
| 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 | 3 |
| Brand Name | FETAL SPIRAL ELECTRODE |
| Generic Name | FETAL SPIRAL ELECTRODE, SINGLE |
| Product Code | HGP |
| Date Received | 2018-08-31 |
| Returned To Mfg | 2018-10-11 |
| Model Number | 989803137631 |
| Lot Number | 171381 |
| 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 | 2018-08-31 |