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

Model Number LW-341DS30/5A

Device Problems Defective Device (2588); Scratched Material (3020)

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

Event Date 09/11/2018

Event Type  malfunction  

Event 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
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): AMC; 11711 nw 39th st; coral springs FL 33065
• MDR Report Key: 7901530
• MDR Text Key: 121516292
• Report Number: 7901530
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00849593034913
• UDI-Public: (01)00849593034913(17)220605(10)170605
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: LW-341DS30/5A
• Device Lot Number: 170605
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1