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

Model Number M1663A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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.A follow up report will be submitted once the investigation is complete.(b)(4).

Event Description

The customer reported that the device was switching from pads to leads, both modes (pads and leads) display the ecg trace.The customer did not report any patient/user involvement.

• Brand Name: 10 LEAD ECG TRUNK AAMI/IEC 2M
• Type of Device: ECG TRUNK CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• Manufacturer Contact: wendy chadbourne ; hewlett-packard str.2; böeblingen 71034 ; GM 71034
• MDR Report Key: 5050731
• MDR Text Key: 25426580
• Report Number: 9610816-2015-00199
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Followup
• Report Date: 08/12/2015

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: M1663A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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