MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 3 LEAD IEC ECG PATIENT CABLE; ECG TRUNK CABLE

Model Number M1510A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  malfunction  

Event Description

The customer reported the m1510a ecg trunk cable needed to be replaced.No further information was provided.There was no reported patient incident/injury.

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.An ecg leads related issue could prevent demand mode pacing or delay therapy/treatment.We are still in the process of assessing if there's a risk to health.This complaint is being reported in order to meet the reporting deadlines.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Manufacturer Narrative

(b)(4).The customer did not provide repair data.

• Brand Name: 3 LEAD IEC ECG PATIENT CABLE
• Type of Device: ECG TRUNK CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 4746235
• MDR Text Key: 5772323
• Report Number: 1218950-2015-02426
• Device Sequence Number: 1
• Product Code: LDD
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K031187
• 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,Followup
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1510A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2015
• Initial Date FDA Received: 05/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2001
• 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