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 2019-05-13 for EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0 865354 manufactured by Philips Medical Systems.
[144817822]
Device evaluated by mfr: a follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[144817823]
The customer reported a serious injury where the customer alleged that the intellivue event management (iem) paging system failed to provide brady and asystole alarm alerts in a timely manner to the staff. The customer stated that from the piic ix to the central station to iem to the cisco phones it took 30 seconds. The customer stated that the iem orchestrator staff assignments escalation process sent the alerts to level1, then level2, then to level3 (charge nurse) where the customer alleged that it took too long to have the sites clinical team respond due to the escalation process delay. The customer alleged that as the escalation happened the patient was not attended to soon enough. The issue occurred on 01/01/2019 at 10:39:28am (in iem ml time) for room (b)(6). The customer stated that there was delay in treatment and the patient required resuscitation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2019-03422 |
| MDR Report Key | 8603316 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-05-13 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-05-06 |
| Device Manufacturer Date | 2011-12-28 |
| Date Added to Maude | 2019-05-13 |
| 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 | 2019-05-13 |
| 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. Required No Informationntervention | 2019-05-13 |