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
Serial number unknown.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The customer reported the trunk cables are eroded.There was no reported patient incident/injury.
Event or Problem Description
The customer reported the trunk cables are eroded.The device was in use on a patient.There was no reported patient incident/injury.

• 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: 8813124
• Report Number: 1218950-2019-05346
• Device Sequence Number: 11350024
• Product Code: MHX
• UDI-Device Identifier: 00884838011632
• UDI-Public: (01)00884838011632
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 5A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/16/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1