MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-30 for PATIENT SAFETYNETTM SYSTEM 24814 9095 manufactured by Masimo - 52 Discovery.
[179251896]
Additional manufacuring narrative: other, other text: remote troubleshooting of the system was performed. It was found that the clinical staff needed to be trained on how to properly assign primary and secondary notification device assignments during the patient admission process. The safetynet system was determined to be functioning as designed. Other text : device not returned.
Patient Sequence No: 1, Text Type: N, H10
[179251897]
The customer reported the format for the primary and secondary naming convention had changed. With this change, the notification to the nurses (secondary notification system) were not firing. No patient impact or consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011353843-2020-00012 |
| MDR Report Key | 9650337 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-11-01 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-01-30 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEFAN LISSMANN |
| Manufacturer Street | 52 DISCOVERY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9492977168 |
| Manufacturer G1 | MASIMO - MEXICALI |
| Manufacturer Street | INDUSTRIAL VALLERA DE MEXICALI CALZADA DEL ORO, NO.2001 |
| Manufacturer City | MEXICALI, BAJA CALIFORNIA 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PATIENT SAFETYNETTM SYSTEM |
| Generic Name | SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS |
| Product Code | MSX |
| Date Received | 2020-01-30 |
| Model Number | 24814 |
| Catalog Number | 9095 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MASIMO - 52 DISCOVERY |
| Manufacturer Address | 52 DISCOVERY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-30 |