MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for PATIENT SAFETYNET CONSOLE manufactured by Masimo Corporation.
[173502487]
Our biomed team received a call that the patient assignments had changed on all of our masimo central appliances. Upon inspection, the format for the primary and secondary naming convention had changed. With this change, our notification to the nurses (secondary notification system) were not firing. Manufacturer response for computer, central station, (brand not provided) (per site reporter). Mfg could determine a route cause on how the change in format occurred. They were able to get the naming format corrected but, this still provided a learning curve for our clinicians who had to learn a new process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9544339 |
| MDR Report Key | 9544339 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-09-30 |
| Date of Event | 2018-11-07 |
| Report Date | 2019-09-30 |
| Date Reported to FDA | 2019-09-30 |
| Date Reported to Mfgr | 2020-01-03 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | PATIENT SAFETYNET CONSOLE |
| Generic Name | SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS |
| Product Code | MSX |
| Date Received | 2020-01-03 |
| Model Number | SAFETYNET |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 YR |
| 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 | 2020-01-03 |