MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 3 LEAD ECG TRUNK CABLE, AAMI/EC 2.7M

Model Number M1669A

Device Problems Data Problem (3196); Patient Data Problem (3197)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

It was reported that there were no additional cables/lead sets with which to perform troubleshooting.No issue details were captured in the call data.No patient incident/injury was reported.

• Brand Name: 3 LEAD ECG TRUNK CABLE, AAMI/EC 2.7M
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer Contact: nancy ataide ; 3000 minuteman road; andover, MA 01810 ; 9786597429
• MDR Report Key: 5292503
• MDR Text Key: 33497147
• Report Number: 9610816-2014-00195
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K020531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1669A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1