MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-11-14 for EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0 865354 manufactured by Philips Medical Systems.
[127119372]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[127119373]
The customer reported that there was a patient death at 10:20am on (b)(6) 2018. The patient was being monitored by a telemetry device and the patient data was sent to a piic ix. And then to an iem intelllispace event management paging system. The customer stated that the asystole alarm was sounded timely at the central station at 10:10am but the pager reported the alarm at 10:25am. It is unknown if there was a delay in treatment due to the alleged untimely paging and further investigation is required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2018-08968 |
| MDR Report Key | 8070091 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-14 |
| Date of Report | 2018-11-08 |
| Date of Event | 2018-11-08 |
| Date Mfgr Received | 2018-11-08 |
| Device Manufacturer Date | 2012-06-06 |
| Date Added to Maude | 2018-11-14 |
| 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 | MS. BETTY HARRIS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0 |
| Generic Name | EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0 |
| Product Code | MSX |
| Date Received | 2018-11-14 |
| Model Number | 865354 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-11-14 |