MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-06-12 for M-LNCS TC-I 2503 manufactured by Masimo - 40 Parker.
| Report Number | 2031172-2019-00283 |
| MDR Report Key | 8694190 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-06-12 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-05-06 |
| Date Mfgr Received | 2019-06-24 |
| Device Manufacturer Date | 2018-06-25 |
| Date Added to Maude | 2019-06-12 |
| 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 | STEFAN LISSMANN |
| Manufacturer Street | 52 DISCOVERY |
| Manufacturer City | IRVINE CA 926181604 |
| Manufacturer Country | US |
| Manufacturer Postal | 926181604 |
| Manufacturer Phone | 9492977168 |
| Manufacturer G1 | MASIMO - MEXICALI |
| Manufacturer Street | INDUSTRIAL VALLERA DE MEXICALI CALZADA DEL ORO, NO.2001 |
| Manufacturer City | MEXICALI, BAJA CALIFORNIA 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | M-LNCS TC-I |
| Generic Name | OXIMETER |
| Product Code | DPZ |
| Date Received | 2019-06-12 |
| Returned To Mfg | 2019-05-27 |
| Model Number | 2503 |
| Catalog Number | 2503 |
| Lot Number | 18FQZ |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO - 40 PARKER |
| Manufacturer Address | 40 PARKER IRVINE CA 926181604 US 926181604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-12 |