MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS CBL 3 LEAD ECG PATIENT TRUNK, AAMI; ECG TRUNK CABLE

Model Number M1500A

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Event Description

The customer reported failure of the m1500a ecg trunk cable.No further information was provided.The customer did not report any patient/user involvement.

Manufacturer Narrative

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

• Brand Name: CBL 3 LEAD ECG PATIENT TRUNK, AAMI
• Type of Device: ECG TRUNK CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: wendy chadbourne ; 3000 minuteman rd.; andover, MA 01810 ; 9788597804
• MDR Report Key: 4743364
• MDR Text Key: 5771727
• Report Number: 1218950-2015-02281
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/02/2015

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: Health Professional
• Device Model Number: M1500A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/02/2015
• Initial Date FDA Received: 04/28/2015
• 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