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 2018-02-08 for EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0 865354 manufactured by Philips Medical Systems.
[99348345]
A follow up report will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[99348346]
On (b)(6) 2018, a philips field service engineer (fse) was at the customed site, and overheard customer biomeds, while they were in contact with the emergin support group. They needed assistance from the emergin tech support to review logs, due to a patient code. The system was is use at the time the issue was discovered. The patient had coded. Patient details, are unknown at the time this report was due.
Patient Sequence No: 1, Text Type: D, B5
[106026138]
There was no philips product malfunction. Based on the provided information, a customer nurse had logged into a voalte system phone, and a second nurse had logged into another voalte system phone with the same serial number. This resulted in the nurse caring for the impacted patient getting canceled from the voalte phone system; therefore, the red alarm alert did not get paged through to this nurse's phone. Further evaluation found that there were two other voalte phones that had been assigned the same serial number. The voalte representative stated that the duplicate phone should be sent back to the manufacturer, because all serial numbers should be unique. The customer will be working with voalte to correct this issue. The philips device remains at the customer site. No further investigation is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218950-2018-01441 |
| MDR Report Key | 7251442 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-02-08 |
| Date of Report | 2018-01-10 |
| Date of Event | 2018-01-04 |
| Date Mfgr Received | 2018-01-10 |
| Device Manufacturer Date | 2013-05-28 |
| Date Added to Maude | 2018-02-08 |
| 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 | EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0 |
| Generic Name | EMERGIN INTELLISPACE EVENT MANAGEMENT VERSION 10.0 |
| Product Code | MSX |
| Date Received | 2018-02-08 |
| 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 | 2018-02-08 |