MAUDE Adverse Event Report: AMC AMC; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	LW-341DS30/5A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
When opening a set of disposable cardiac monitor cables, it was noted that one of the cable wires was exposed out of the covering for about 18 inches.Checked stock in unit and no other packages with the same lot# had defects.

• Brand Name: AMC
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): AMC; 11711 nw 39th st; coral springs FL 33065
• MDR Report Key: 7901530
• Report Number: 7901530
• Device Sequence Number: 1707545
• Product Code: DSA
• UDI-Device Identifier: 00849593034913
• UDI-Public: (01)00849593034913(17)220605(10)170605
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2018
• Report Date (Section F): 09/13/2018

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: No Information
• Device Model Number: LW-341DS30/5A
• Device Lot Number: 170605
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/13/2018