MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-09-25 for INVOS 5100C manufactured by Mitg - Galway.
| Report Number | 8020893-2019-00190 |
| MDR Report Key | 9121060 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-09-25 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-07-01 |
| Date Mfgr Received | 2019-08-29 |
| Date Added to Maude | 2019-09-25 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBWOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 3035306582 |
| Manufacturer G1 | MITG - GALWAY |
| Manufacturer Street | NEW MERVUE INDUSTRIAL PARK |
| Manufacturer City | GALWAY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVOS |
| Generic Name | OXIMETER, TISSUE SATURATION |
| Product Code | MUD |
| Date Received | 2019-09-25 |
| Model Number | 5100C |
| Catalog Number | 5100C |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MITG - GALWAY |
| Manufacturer Address | NEW MERVUE INDUSTRIAL PARK GALWAY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-25 |