MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M

Model Number M1668A

Device Problems Device Operates Differently Than Expected (2913); Failure of Device to Self-Test (2937)

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.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.(b)(4).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.

Event Description

The customer reported the m1668a ecg triunk cable failed during the device self test.There was no reported patient incident/injury.

Event Description

The customer reported the m1668a ecg trunk cable failed during the device self test.There was no reported patient incident/injury.

• Brand Name: 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M
• 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: 5027476
• MDR Text Key: 24161923
• Report Number: 9610816-2015-00186
• 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: Followup
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1668A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2015
• 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