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
Cannot 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
The customer ordered a replacement part without device evaluation.
Event or Problem Description
The customer reported a failure of the ecg trunk cable.There was no patient involved.

• 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: 9727411
• Report Number: 1218950-2020-01160
• Device Sequence Number: 3129398
• Product Code: MHX
• 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,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1