MAUDE Adverse Event Report: ADVANTAGE MEDICAL ELECTRONICS, LLC AMC 5 LEAD DISPOSABLE DIN TO PINCH; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number	LWM-329DS50/5A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Cvor (cardiovascular operating room): during procedure, amd 5 lead cables were difficult to attach.Connection was tight into the main ecg cable.Ecg worked for a short time, then the v lead did not work.It would return intermittently.Another cable used without further problems.No known harm to patient, minor delay in procedure.Manufacturer response for cable, transducer and electrode, patient, (including connector), amc (per site reporter), will obtain.

• Brand Name: AMC 5 LEAD DISPOSABLE DIN TO PINCH
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): ADVANTAGE MEDICAL ELECTRONICS, LLC; 11705 nw 39th street; coral springs FL 33065
• MDR Report Key: 17563169
• Report Number: 17563169
• Device Sequence Number: 12497574
• Product Code: DSA
• UDI-Device Identifier: 00849593016384
• UDI-Public: (01)00849593016384(11)220707(10)AE220707-B
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/15/2023
• Report Date (Section F): 08/15/2023

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: LWM-329DS50/5A
• Device Lot Number: AE220707-B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/15/2023