MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 5 LEAD ECG PATIENT TRUNK CABLE SAFETY SET - LARGE; CABLE, ELECTRODE

Device Problem Use of Device Problem (1670)

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

Event Date 01/31/2017

Event Type  malfunction  

Event Description

The pt has a history of intentional ingestion.The patient was touching a cardiac monitoring wire.A portion of plastic shear to cord was noted to be missing with frayed wires exposed.

• Brand Name: 5 LEAD ECG PATIENT TRUNK CABLE SAFETY SET - LARGE
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 6398553
• MDR Text Key: 69758869
• Report Number: 6398553
• Device Sequence Number: 1
• Product Code: IKD
• 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: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2017
• 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