MAUDE Adverse Event Report: INVIVO CORPORATION INVIVO CORPORATION; PATIENT MONITOR

Model Number 865485

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

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 initially reported that the ¿speaker does not work optimally¿.This was later described as the sound of the alarm being disturbed and that sometimes there was no sound at all and sometimes it was working fine.There was no reported patient and/or user impact as a result of the reported problem.The device was not in use when the issue was discovered.

Event Description

The customer initially reported that the ¿speaker does not work optimally¿.This was later described as the sound of the alarm being disturbed and that sometimes there was no sound at all and sometimes it was working fine.The issue was discovered by philips personnel during preventive maintenance of the device.There was no reported patient and/or user impact as a result of the reported problem.The device was not in use when the issue was discovered.

• Brand Name: INVIVO CORPORATION
• Type of Device: 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: wendy chadbourne ; 12151 research parkway; suite 200; orlando, FL 32826
• MDR Report Key: 6116431
• MDR Text Key: 60865813
• Report Number: 1051786-2016-00016
• Device Sequence Number: 1
• Product Code: MWI
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K053462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

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: Health Professional
• Device Model Number: 865485
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2012
• 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