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 2018-01-24 for INTELLISPHERE EVENT MANAGEMENT 866030 manufactured by Philips Medical Systems.
[98085769]
Patient information as been requested. A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[98085770]
The customer reported that on (b)(6) 2018, as alarming stopped through the paging (iem) system at 10:17am. The patient leads off of telemetry starting happening at 17:30pm, and no iem leads off alerts were received. At 19:00, they found the patient in room 335 in 3 south expired. The patient died.
Patient Sequence No: 1, Text Type: D, B5
[107451104]
The paging interface was operational and worked as expected earlier in the day between (b)(6). However, the customer said the patient had an event at (b)(6); no paging data for that bed at that time or after was available, and it is not known what the input/monitoring system was doing during that time, due to the monitoring system being a ge product, not a philips product. The pse also indicated that if the ge system monitor had a? Leads off? Alert, no patient data from ge would be received. However, further investigation of the report that the patient leads off of telemetry starting happening at (b)(6) and no iem leads off alerts were received, could not be performed, as the logs needed to for the investigation from ge were not available. Therefore, philips could not rule out a malfunction, or that the failure to page may have been a factor in this event. The customer was directed to have the vendor ge parse its systems logs. The customer had no further questions for philips, and confirmed that they had informed ge of the issue. No further investigation is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-00656 |
| MDR Report Key | 7215509 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-24 |
| Date of Report | 2018-01-12 |
| Date of Event | 2018-01-11 |
| Date Mfgr Received | 2018-01-12 |
| Device Manufacturer Date | 2016-02-05 |
| Date Added to Maude | 2018-01-24 |
| 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 |
| 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 | 2018-01-24 |
| 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 | 2018-01-24 |