MAUDE Adverse Event Report: HILL-ROM, INC. NAVICARE WATCHCHILD; MONITOR

Device Problem Erratic or Intermittent Display (1182)

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

Event Date 10/28/2014

Event Type  malfunction  

Event Description

Navicare watchchild external fetal monitoring system flickering on and off.Able to view data on monitor paper in patient's room.

• Brand Name: NAVICARE WATCHCHILD
• Type of Device: MONITOR
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 4252907
• MDR Text Key: 4992336
• Report Number: 4252907
• Device Sequence Number: 1
• Product Code: HGM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2014
• Patient Sequence Number: 1