MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-12 for RADIUS-7 9837 manufactured by Masimo Corporation.
[178761550]
Found that this instrument board measures saturation of hemoglobin with oxygen as measured by pulse oximetry (spo2) inaccurately. In various testing it was isolated to this device, other compatible battery and root devices will not change the effect of the error. The device measures spo2 inaccurately. Accuracy ranges from a minimum 4% difference (4. 1% error) to 63 % difference (65% error). The testing was conducted on two different fluke prosim 8's within calibration spec, and spot spo2 testers. Simulation devices were set for masimo settings at 97% perfusion. Measurements ranged from 34%-93%. Manufacturer response for masimo radius 7 instrument board, masimo (per site reporter). Requested the device for evaluation. No further response at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9699209 |
| MDR Report Key | 9699209 |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-03 |
| Date of Event | 2020-01-23 |
| Report Date | 2020-02-03 |
| Date Reported to FDA | 2020-02-03 |
| Date Reported to Mfgr | 2020-02-12 |
| Date Added to Maude | 2020-02-12 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | RADIUS-7 |
| Generic Name | OXIMETER |
| Product Code | DQA |
| Date Received | 2020-02-12 |
| Returned To Mfg | 2020-02-03 |
| Model Number | 9837 |
| Device Availability | R |
| Device Age | 5 MO |
| 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 | 2020-02-12 |