MAUDE Adverse Event Report: VISICU, INC - DUP ECAREMANAGER SYSTEM

Model Number	865325
Health Effect - Clinical Code	Death (1802)
Date of Event	04/13/2018
Type of Reportable Event	Death
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
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.

• Brand Name: ECAREMANAGER SYSTEM
• Common Device Name: ECAREMANAGER
• Manufacturer (Section D): VISICU, INC - DUP; 217 e redwood st ste 1900; baltimore MD 21202
• MDR Report Key: 7513903
• Report Number: 1125873-2018-00001
• Device Sequence Number: 19272068
• Product Code: MSX
• UDI-Device Identifier: 00884838059832
• UDI-Public: (01)00884838059832(10)4.1.1
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K153156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 865325
• Device Catalogue Number: 865325
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 04/13/2018; 04/13/2018
• Initial Report FDA Received Date: 05/15/2018
• Supplement Report FDA Received Date: 06/15/2018; 07/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR