MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for MASIMO RADICAL-7 9500 manufactured by Masimo Corporation.
[183098503]
Unable to obtain o2 saturation. Biomed was unable to identify any issue or replicate. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9823318 |
| MDR Report Key | 9823318 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-03 |
| Report Date | 2020-03-10 |
| Date Reported to FDA | 2020-03-10 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MASIMO RADICAL-7 |
| Generic Name | OXIMETER |
| Product Code | DQA |
| Date Received | 2020-03-12 |
| Model Number | 9500 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO CORPORATION |
| Manufacturer Address | 52 DISCOVERY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |