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 2020-01-15 for FETAL SPIRAL ELECTRODE 989803137631 manufactured by Philips Medical Systems.
[175084130]
A follow-up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[175084131]
The customer reported that the coil was reported missing after examination. The device was in use on a patient. Patient outcome is currently unknown.
Patient Sequence No: 1, Text Type: D, B5
[183432484]
The material was not available for further evaluation. Because of this, we are considering this to be a malfunction of unknown cause/insufficient information. There were no further details of the infants condition. Staff training was provide by the registar.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2020-00315 |
| MDR Report Key | 9592307 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-12-22 |
| Date Mfgr Received | 2020-01-14 |
| Date Added to Maude | 2020-01-15 |
| 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 | 2020-01-15 |
| Model Number | 989803137631 |
| Catalog Number | 989803137631 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-15 |