MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-12 for INTELLISPHERE EVENT MANAGEMENT 866030 manufactured by Philips Medical Systems.
[105311109]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[105311110]
The customer called asking for paging log information from (b)(6) 2018 between 03:00 to 03:45 to see all alarms to the cisco phones that were assigned to room 332 that were sent by the emergin paging system. There was a patient death and the customer wanted to do follow-up data collection. Further investigation is required to understand if the paging system caused or contributed to the patient event.
Patient Sequence No: 1, Text Type: D, B5
[114199045]
There is no data to support an iem (intellispace event management) malfunction. The iem message log shows that the nicu float nurse was sent the brady alarm message at 03:19:15. Based on the information provided it can not be ruled out that the iem paging system may have been a factor in the adverse event although there was no allegation that any philips caused or contributed to the adverse event. There is no data to support a philips device malfunction associated with the iem paging system itself. The iem (intellispace event management) paging system is labeled as a means of alarm information notification. Issues with paging would not prevent the monitoring device from continuing to provide real-time monitoring and alarms. The system is not intended to provide real-time information, nor is it the source of alarms, nor is it a replacement for alarming devices. Therefore this issue would not be likely to cause or contribute to death or serious injury if the paging device is used per product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-03335 |
| MDR Report Key | 7425892 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-12 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-03-09 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 2011-09-30 |
| Date Added to Maude | 2018-04-12 |
| 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 | INTELLISPHERE EVENT MANAGEMENT |
| Generic Name | COMMUNICATION SYSTEM |
| Product Code | MSX |
| Date Received | 2018-04-12 |
| Model Number | 866030 |
| 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 | 2018-04-12 |