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

Model Number M1949A

Device Problem Device Sensing Problem (2917)

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

Event Type  malfunction  

Event Description

The customer reported problems with 12 lead ecg signal acquisition.No patient incident/injury was reported.

Manufacturer Narrative

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

• Brand Name: CBL 5+5 ECG TRUNK CABLE AAMI, IEC 2.7M
• Type of Device: ECG TRUNK CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810 109
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman rd.; andover, MA 01810-1099 ; 9786597804
• MDR Report Key: 4287789
• MDR Text Key: 18627718
• Report Number: 1218950-2014-06878
• Device Sequence Number: 1
• Product Code: DPS
• 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: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1949A
• Device Lot Number: 3D
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/23/2014
• 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