MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-29 for SENSOR, NEONATE LNCS 1862 * manufactured by Masimo Corporation.
[20294507]
Pulse ox probe failed to register x two. Happened with two different monitors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3879430 |
| MDR Report Key | 3879430 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-05-22 |
| Date of Event | 2014-02-26 |
| Report Date | 2014-05-22 |
| Date Reported to FDA | 2014-05-29 |
| Date Reported to Mfgr | 2014-06-18 |
| Date Added to Maude | 2014-06-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSOR, NEONATE LNCS |
| Generic Name | OXIMETER, EAR |
| Product Code | DPZ |
| Date Received | 2014-05-29 |
| Returned To Mfg | 2014-03-18 |
| Model Number | 1862 |
| Catalog Number | * |
| Lot Number | 4A311 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO CORPORATION |
| Manufacturer Address | 40, 50 & 60 PARKER IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-29 |