MAUDE Adverse Event Report: VISICU, INC - DUP PHILIPS TELEHEALTH SYSTEM; PTS CUI

Model Number M3810

Device Problems Loss of Data (2903); Issue With Displayed Error Message (2967)

Patient Problem Death (1802)

Event Date 04/02/2017

Event Type  Death  

Manufacturer Narrative

Philips q&r has investigated the reported failure of alert flags spontaneously clearing for a single patient.This complaint has not been confirmed.Investigation revealed that all the patient¿s measurements on (b)(6) 2017 were out of range and generating alert flags.These alert flags were acknowledged and cleared with no notes by a single user identification at the customer site.The philips patient telemonitoring set is working as designed.During the course of this investigation, philips became aware that the patient was admitted to the hospital on the same day the telehealth nurse perceived that alert flags were spontaneously cleared ((b)(6) 2017).Patient passed away on (b)(6) 2017 though this was not reported by the customer.This event is not related to any failure of a philips device.Q&r will continue to monitor for trends.

Event Description

Customer reported that alert flags from (b)(6) 2017 were spontaneously cleared for a single patient using the philips patient telemonitoring set.Telehealth nurse was not aware of the alerts and there were no event notes.Patient was admitted to the hospital on the same day ((b)(6) 2017) and passed away on (b)(6) 2017.

• Brand Name: PHILIPS TELEHEALTH SYSTEM
• Type of Device: PTS CUI
• Manufacturer (Section D): VISICU, INC - DUP; 217 e redwood st ste 1900; baltimore MD 21202
• Manufacturer (Section G): VISICU, INC.; 217 e redwood st ste 1900; baltimore MD 21202
• Manufacturer Contact: justin minor ; 217 e redwood st ste 1900; baltimore, MD 21202
• MDR Report Key: 6489434
• MDR Text Key: 72670067
• Report Number: 1125873-2017-00005
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

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
• Device Operator: Health Professional
• Device Model Number: M3810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 04/04/2017
• Supplement Dates FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 93 YR
• Patient Weight: 39