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 2019-07-16 for AIRLIFE? INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE?, PANDA?) 2075796-001 manufactured by Vyaire Medical.
| Report Number | 3005934741-2019-00002 |
| MDR Report Key | 8792894 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-07-16 |
| Date of Report | 2019-06-18 |
| Date of Event | 2019-02-15 |
| Date Mfgr Received | 2019-11-19 |
| Date Added to Maude | 2019-07-16 |
| 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 | 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 | THERMOMETRICS DE MEXICO S.A. DE C.V |
| Manufacturer Street | CALLE SIETE NORTE NO 110 CIUDAD INDUSTRIAL OTAY |
| Manufacturer City | TIJUANA, 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE? INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE?, PANDA?) |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2019-07-16 |
| Catalog Number | 2075796-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2019-07-16 |