MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-07 for INVOS 5100C manufactured by Mitg Galway.
[178422871]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178422872]
According to the reporter, the device gave a high rso2 reading, 57 on the left and 63 on the right, even without brain activity. The patient was deceased. Per the follow up information provided by the customer, the patient was not being monitored with the device at the time of death in the icu. The device is not related to the patient death of multi-organ failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020893-2020-00018 |
| MDR Report Key | 9683041 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date Mfgr Received | 2019-09-20 |
| Date Added to Maude | 2020-02-07 |
| 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 | AVI KLUGER |
| Manufacturer Street | 5920 LONGBOW 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 |
| Manufacturer Country | IE |
| 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 | 2020-02-07 |
| 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 IE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |