MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-12-20 for VITAL SIGNS? FETAL SPIRAL ELECTRODE FOR COROMETRICS 7000AAO manufactured by Vyaire Medical.
[131065602]
Vyaire complaint (b)(4). Any additional information provided by the customer will be included in a follow-up report. Due diligence is ongoing. At this time, vyaire is pursuing additional information and sample availability for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[131065603]
A customer contacted vyaire medical to report that two wires (pink & blue) seemed to be twisted in the wrong direction. When the end user was attempting to pull the wires apart to disengage from the (unborn) baby's head, instead of the small corkscrew wire that is at the end of the electrode unscrewing, it was screwing deeper into the unborn baby's head. This is the first time the end user customer experienced the issue. There was no indication of patient harm or medical intervention during initial contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003678543-2018-00001 |
| MDR Report Key | 8184893 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-20 |
| Date of Report | 2018-11-30 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-11-30 |
| Date Added to Maude | 2018-12-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | PRECISION CONCEPTS COSTA RICA SA |
| Manufacturer Street | SARET FREE ZONE BUILDING D3 P.O. BOX 74-4002 |
| Manufacturer City | ALAJUELA, |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SIGNS? FETAL SPIRAL ELECTRODE FOR COROMETRICS |
| Generic Name | ELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR |
| Product Code | HGP |
| Date Received | 2018-12-20 |
| Catalog Number | 7000AAO |
| Lot Number | S07181-F, S35171-F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |