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

Model Number M1663A

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

The customer reported the failure of an m1663a ecg trunk cable, it was also reported that 12 lead ecg monitoring was not possible.No patient incident/ injury was reported.

Manufacturer Narrative

(b)(4).A f/u report will be submitted once the investigation is complete.

• Brand Name: 10 LEAD ECG TRUNK AAMI/IEC 2M
• Type of Device: DSA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman rd; andover, MA 01810 ; 9786597804
• MDR Report Key: 4392394
• MDR Text Key: 5124878
• Report Number: 9610816-2014-00284
• 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: 07/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2014
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/29/2014
• 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