MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-24 for ECG ELECTRODES, NEONATAL, RADIOLUCENT, PRE-WIRED WITH DIN 3-LEAD SET, AHA 2009101-404 manufactured by Vyaire Medical.
[146387762]
Vyaire complaint number: (b)(4). At this time, vyaire has not received the suspect device/component for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[146387763]
A customer reported to vyaire medical two leads had come apart from the electrode, exposing the ends of the wires when removing the electrodes from an infant. This happened twice involving the same infant. The customer explained that the probe was not removed. After the monitor alarmed, they had un-swaddled the baby and found the lead was not attached to the gel sticky. No visible defects/damages noted on the probe prior to or during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010838917-2019-00001 |
| MDR Report Key | 8642236 |
| Date Received | 2019-05-24 |
| Date of Report | 2019-04-30 |
| Date of Event | 2019-04-24 |
| Date Mfgr Received | 2019-04-25 |
| Date Added to Maude | 2019-05-24 |
| 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 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | BIO PROTECH, INC. |
| Manufacturer Street | 151-3 DONGHWAGONGDAN-RO, |
| Manufacturer City | MUNMAKE-EUP, GANGWON-DO 26365 |
| Manufacturer Country | KS |
| Manufacturer Postal Code | 26365 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ECG ELECTRODES, NEONATAL, RADIOLUCENT, PRE-WIRED WITH DIN 3-LEAD SET, AHA |
| Generic Name | ELECTRODE, ELECTROCARDIOGRAPH |
| Product Code | DRX |
| Date Received | 2019-05-24 |
| Catalog Number | 2009101-404 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-05-24 |