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.
[183128717]
Term c-section was delivered, placed on radiant heated warmer. Infant received positive pressure ventilation (ppv) and the pulse ox. Was placed on the right wrist per neonatal resuscitation (nrp) guidelines. However, the mossimo was able to read the heartrate, but failed to read the oxygen saturation. Nurse left to grab another mossimo located on a nearby cart, but that mossimo was also able to read the heart rate but unable to read the oxygen saturation of the baby. This nurse again left to obtain a yellow portable pulse oximeter from a labor and delivery room. That pulse oximeter was finally able to read the oxygen saturation of the baby at ~7 minutes of age. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9824032 |
| MDR Report Key | 9824032 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-28 |
| 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 | * |
| 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 |