MAUDE Adverse Event Report: INVIVO CORPORATION PHILIPS EXPRESSION INFORMATION PORTAL (IP5); PHYSIOLOGICAL PATIENT MONITOR

Model Number 865471

Device Problem Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the device was not producing any alarms and that the alarms appear to be muted.Technical support (ts) checked volume settings and found them to be appropriate.There was no reported patient impact.

Event Description

The customer reported that the device was not producing any alarms and that the alarms appear to be muted.It was later clarified that both the alarm sound and all other sounds (touch and qrs tone) were not working.Technical support (ts) checked volume settings and found them to be appropriate.The biomed stated he tried turning the ip5 off and on but still no sound.There was no report of a death or serious injury, nor was there a report of any adverse impact to any user or patient.The device was being used for patient monitoring when the problem occurred.

• Brand Name: PHILIPS EXPRESSION INFORMATION PORTAL (IP5)
• Type of Device: PHYSIOLOGICAL PATIENT MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; suite 200; andover, MA 01810 ; 9786871501
• MDR Report Key: 5977812
• MDR Text Key: 56005222
• Report Number: 1051786-2016-00012
• Device Sequence Number: 1
• Product Code: MWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121424
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 865471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2015
• 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