MAUDE Adverse Event Report: PHILIPS MEDISIZE COSTA MESA, LLC PHILIPS LEADS; CABLE TRANSDUCER AND ELECTRODE, PATIENT

Model Number M1968A

Device Problem Output Problem (3005)

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

Event Date 11/20/2018

Event Type  malfunction  

Event Description

It was reported that the ekg leads stopped working while on pt during a robotic procedure.

• Brand Name: PHILIPS LEADS
• Type of Device: CABLE TRANSDUCER AND ELECTRODE, PATIENT
• Manufacturer (Section D): PHILIPS MEDISIZE COSTA MESA, LLC
• MDR Report Key: 8101684
• MDR Text Key: 128405934
• Report Number: MW5081572
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1968A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1