MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-05-15 for ECAREMANAGER SYSTEM 865325 manufactured by Visicu, Inc - Dup.
[108241335]
Patient Sequence No: 1, Text Type: N, H10
[108241336]
The preliminary investigation into the events of (b)(6) 2018, by philips, revealed the following information. At 1:42 am? Vital signs message data stopped for the patient. At 1:45 am? Bp values received for the final time. At 1:51 am? Vitals stopped notification was sent to all running workstations. This notification was not dismissed and remained on screen for an hour before being auto-dismissed by the system. At 3:27 am? Heart rate data received. At 3:47 am? Patient was discharged from the eicu system due to their passing. During the time between measurement, messages were received but contained no values to post. This patient was a low acuity patient and was on an infrequent rounding schedule by the eicu staff. When the eicu nurse did round on the patient, using the in room audio/visual equipment, the nurse noticed that the patient was unresponsive and that patient monitoring leads were off the patient and could be seen lying on the bed. The nurse then contacted the bedside staff and relayed their findings. Philips preliminary investigation concludes that the eicu system performed as designed. This device is not used in the treatment or diagnosis of patients, according to the device's intended use. Contrary to the customer report, the vitals stopped notification was sent. In addition, the proof of performance is shown by the continued receipt of messages containing no data values, and the receipt of vital data at 3:27 am. At the current time the customer is performing an internal investigation into this incident. The results of this investigation will be transmitted to philips once they are available. Following this philips will send updates or further submissions.
Patient Sequence No: 1, Text Type: D, B5
[111545964]
Following submission of the initial emdr we, philips, have endeavored to obtain information regarding the internal investigation by (b)(6) medical center. To that end we have send requests for more information on may 17, 2018 and june 1, 2018. In responses dated may 18, 2018 and june 1, 2018 we were informed that there were no updates at that time. We will continue to monitor for a further response and will update as information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[113520263]
Following submission of the initial follow up, we, philips, sent a third request to obtain information regarding the internal investigation by (b)(6) medical center on june 28, 2018. In a response also dated june, 28, 2018 we were informed that there were no updates at that time. At this time we consider the matter closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1125873-2018-00001 |
| MDR Report Key | 7513903 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-05-15 |
| Date of Report | 2018-04-16 |
| Date of Event | 2018-04-13 |
| Date Mfgr Received | 2018-04-13 |
| Date Added to Maude | 2018-05-15 |
| 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 | MR. JUSTIN MINOR |
| Manufacturer Street | 217 E REDWOOD ST STE 1900 |
| Manufacturer City | BALTIMORE MD 21202 |
| Manufacturer Country | US |
| Manufacturer Postal | 21202 |
| Manufacturer G1 | VISICU, INC. |
| Manufacturer Street | 217 E REDWOOD ST STE 1900 |
| Manufacturer City | BALTIMORE MD 21202 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ECAREMANAGER SYSTEM |
| Generic Name | ECAREMANAGER |
| Product Code | MSX |
| Date Received | 2018-05-15 |
| Model Number | 865325 |
| Catalog Number | 865325 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISICU, INC - DUP |
| Manufacturer Address | 217 E REDWOOD ST STE 1900 BALTIMORE MD 21202 US 21202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-15 |