MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CBL 3 LEAD ECG TRUNK, AAMI/EC 2.7M

Model Number M1669A

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported to philips healthcare that the device was not showing ecg (measurement data).No patient harm was reported.

Manufacturer Narrative

Pr#: (b)(4).

• Brand Name: CBL 3 LEAD ECG TRUNK, AAMI/EC 2.7M
• Type of Device: NA
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: kelly rector ; 3000 minuteman rd.; andover, MA 01810 ; 9786592590
• MDR Report Key: 4188509
• MDR Text Key: 5096027
• Report Number: 1218950-2014-05931
• Device Sequence Number: 1
• Product Code: MHX
• 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,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/04/2014

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: Other
• Device Model Number: M1669A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2014
• Initial Date FDA Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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