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

Model Number LWM-329DS50/5A

Device Problem Device Sensing Problem (2917)

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

Event Date 08/08/2022

Event Type  malfunction  

Event 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
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): AMC; 11705 nw 39th street; coral springs FL 33065
• MDR Report Key: 15282367
• MDR Text Key: 298476285
• Report Number: 15282367
• Device Sequence Number: 1
• Product Code: DSA
• UDI-Device Identifier: 00849593016384
• UDI-Public: (01)00849593016384(11)220104(10)AE220104
• 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: 08/10/2022

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
• Device Operator: 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
• Date Report Sent to FDA: 08/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1