MAUDE Adverse Event Report: PHILIPS HEALTHCARE; EKG MONITOR

Model Number MP50

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/11/2018

Event Type  malfunction  

Event Description

Ekg monitor not working properly.Multiple attempts to troubleshoot.House supervisor called, nicu chg called.Portable monitor brought in at this time.

• Type of Device: EKG MONITOR
• Manufacturer (Section D): PHILIPS HEALTHCARE; 3000 minuteman road; andover MA 01810
• MDR Report Key: 7490347
• MDR Text Key: 107472368
• Report Number: 7490347
• Device Sequence Number: 1
• Product Code: DRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2018,04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MP50
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1