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

Model Number 865353

Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.

Event Description

The customer reported that there is no sound coming through the device.The device was not in use on a patient.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INVIVO CORPORATION
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): INVIVO CORPORATION; 12151 research parkway; suite 200; orlando FL 32826
• MDR Report Key: 8245283
• MDR Text Key: 133223037
• Report Number: 1051786-2019-00002
• Device Sequence Number: 1
• Product Code: DQA
• UDI-Device Identifier: 00884838012585
• UDI-Public: (01)00884838012585
• Combination Product (y/n): N
• PMA/PMN Number: K103700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1