MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 10 LEAD ECG TRUNK AAMI/IEC 2M

Model Number M1663A

Device Problem Failure to Capture (1081)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported the failure of an m1663a ecg trunk cable, in which there was a failure to capture a 12 lead ecg signal.There was no pt injury; however, there was a delay in monitoring while another cable was delivered to the site (where the mrx was being used to monitor the pt).

Manufacturer Narrative

(b)(4): a follow-up report will be submitted once the investigation is completed.

• Brand Name: 10 LEAD ECG TRUNK AAMI/IEC 2M
• 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: 3773481
• MDR Text Key: 4380244
• Report Number: 9610816-2014-00080
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020531
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M1663A
• Device Lot Number: 3D
• Date Manufacturer Received: 03/18/2014
• 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