MAUDE Adverse Event Report: PHILIPS MEDICAL CABLE; LEADS

Model Number CABLE

Device Problems No Display/Image (1183); Defective Component (2292)

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

Event Date 04/20/2016

Event Type  malfunction  

Event Description

Ekg trace on bedside monitor did not display.Noticed immediately by bedside nurse.Electrodes replaced.Ekg trace on bedside monitor again did not display with intermittent signaling.Ekg cable and leads removed from bedside and replaced with a new set of leads and cable.

• Brand Name: CABLE
• Type of Device: LEADS
• Manufacturer (Section D): PHILIPS MEDICAL; andover ME 01810
• MDR Report Key: 5624451
• MDR Text Key: 44217985
• Report Number: MW5062013
• Device Sequence Number: 2
• Product Code: IKD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CABLE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR