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

Model Number M1669A

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Manufacturer Narrative

Unable to confirm serial number.A follow-up report will be submitted once the investigation is complete.

Event Description

The customer reported a failure of the ecg trunk cable.Patient involvement is unknown.There was no reported patient incident/injury.

Manufacturer Narrative

A replacement order was initiated.The material was requested for failure analysis but to date no material has been returned.If material is returned the complaint will be reopened and further processed.

Event Description

The customer reported a failure of the ecg trunk cable.The device was not in use on a patient.

• Brand Name: CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M
• Type of Device: TRUNK CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: robert corning ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 9636551
• MDR Text Key: 181399303
• Report Number: 1218950-2020-00632
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00884838011632
• UDI-Public: (01)00884838011632
• 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,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

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: M1669A
• Device Catalogue Number: 989803145071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 03/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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