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

Model Number M1520A

Device Problems Peeled/Delaminated (1454); Use of Device Problem (1670)

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

Event Date 02/20/2017

Event Type  malfunction  

Event Description

The patient peeled off the outer coating of the ecg monitor cord.Pieces of the device were found, we are unsure if the patient ingested any of the pieces.

• Brand Name: 5 LEAD ECG PATIENT TRUNK CABLE SAFETY SET - SMALL
• Type of Device: CABLE, ELECTRODE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd .; andover MA 01810
• MDR Report Key: 6398568
• MDR Text Key: 69758989
• Report Number: 6398568
• 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
• Device Model Number: M1520A
• Other Device ID Number: 989803103941
• 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