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

Model Number M1668A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The customer reported a failure to measure ecg.No patient incident/injury was reported.

Manufacturer Narrative

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

• Brand Name: 5 LEAD ECG TRUNK CABLE, AAMI/IEC 2.7M
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman rd; andover, MA 01810 ; 9786597804
• MDR Report Key: 4265386
• MDR Text Key: 17275962
• Report Number: 9610816-2014-00288
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2014
• 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?: Yes
• Date Manufacturer Received: 10/09/2014
• 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