MAUDE Adverse Event Report: AMC AMC; 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	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure in cardiovascular operating room (cvor), the amc 5 lead disposable was used.The only lead that gave a signal was iii.This was attempted 2 more times, with 2 more devices, with the same results (all 3 devices had the same lot number).Manufacturer response for cable, transducer and electrode, patient, (including connector), amc (per site reporter): will obtain.

• Brand Name: AMC
• Common Device Name: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): AMC; 11705 nw 39th street; coral springs FL 33065
• MDR Report Key: 15282367
• Report Number: 15282367
• Device Sequence Number: 19415436
• Product Code: DSA
• UDI-Device Identifier: 00849593016384
• UDI-Public: (01)00849593016384(11)220104(10)AE220104
• 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): 08/10/2022
• Report Date (Section F): 08/10/2022

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: AE220104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/10/2022