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

Model Number	M1669A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unable to confirm serial number.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported a failure of the ecg trunk cable.Patient involvement is unknown.There was no reported patient incident/injury.
Additional 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 or Problem 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
• Common Device Name: TRUNK CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9636551
• Report Number: 1218950-2020-00632
• Device Sequence Number: 13599784
• Product Code: DSA
• UDI-Device Identifier: 00884838011632
• UDI-Public: (01)00884838011632
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K020531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: M1669A
• Device Catalogue Number: 989803145071
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1