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

Model Number 865353

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer reported that no alarm sound was coming from the device.The device was not in use on a patient.There was no reported patient impact.

• 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: robert corning ; 12151 research parkway; suite 200; orlando, FL 32826
• MDR Report Key: 8392852
• MDR Text Key: 139881424
• Report Number: 1051786-2019-00012
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00884838012585
• UDI-Public: (01)00884838012585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103700
• 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
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865353
• Device Catalogue Number: 865353
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2013
• 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