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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 321326988
• Report Number: 17563169
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00849593016384
• UDI-Public: (01)00849593016384(11)220707(10)AE220707-B
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 08/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other