MAUDE Adverse Event Report: PHYSIO CONTROL 12 LEAD CABLE; GREY 12 LEAD CABLE

Model Number 12 LEAD CABLE "GREY"

Device Problems Failure to Read Input Signal (1581); Device Operates Differently Than Expected (2913)

Patient Problem Dyspnea (1816)

Event Date 12/27/2013

Event Type  malfunction  

Event Description

Twelve lead cables would not document v6 on female complaining of "short of breath".No injury to patient reported.

• Brand Name: 12 LEAD CABLE
• Type of Device: GREY 12 LEAD CABLE
• Manufacturer (Section D): PHYSIO CONTROL; redmond WA 98052
• MDR Report Key: 3670334
• MDR Text Key: 4344057
• Report Number: MW5034840
• Device Sequence Number: 1
• Product Code: LDD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12 LEAD CABLE "GREY"
• Other Device ID Number: 11111-0000022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR