MAUDE Adverse Event Report: REMINGTON MEDICAL, INC. 6 FOOT DISPOSABLE EXTENSION CABLE WITH SAFE CONNECT / SCREW-DOWN; CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

Model Number FL-601-97

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

Event Date 05/08/2024

Event Type  malfunction  

Event Description

"cable prongs faulty." manufacturer response for pacing cable, remington (per site reporter).They sent us replacement product and will investigate when they receive the faulty one back.

• Brand Name: 6 FOOT DISPOSABLE EXTENSION CABLE WITH SAFE CONNECT / SCREW-DOWN
• Type of Device: CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
• Manufacturer (Section D): REMINGTON MEDICAL, INC.; 6830 meadowridge court; alpharetta GA 30005
• MDR Report Key: 17595087
• MDR Text Key: 321641176
• Report Number: 17595087
• Device Sequence Number: 1
• Product Code: DSA
• 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: 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 Model Number: FL-601-97
• Device Catalogue Number: FL-601-97
• Device Lot Number: 2230016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1