MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC MRW2515 AND MRW3015; MR CONDITIONAL WEBB ELECTRODES

Model Number MRW2515 AND MRW3015

Device Problems Material Separation (1562); No Visual Prompts/Feedback (4021)

Patient Problem Choking (2464)

Event Date 09/21/2021

Event Type  malfunction  

Manufacturer Narrative

Rhythmlink international, llc opened an investigation to ascertain the root cause of the event, and subsequently reviewed production records.No non-conformances were identified.The customer did not return the defective product for review.The investigation is ongoing, and the root cause has not been identified at the time of this report.

Event Description

Rhythmlink international, llc received notification from a customer that the heat shrink applied to the cable assembly of an individual mr conditional lead wire was slipping off of the male din connector.

• Brand Name: MRW2515 AND MRW3015
• Type of Device: MR CONDITIONAL WEBB ELECTRODES
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC; 1140 1st street south; columbia SC 29209
• MDR Report Key: 12667528
• MDR Text Key: 280076257
• Report Number: 1067162-2021-00003
• Device Sequence Number: 1
• Product Code: GXY
• UDI-Device Identifier: 10816312024439
• UDI-Public: (01)10816312024422_AND_(01)10816312024439
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MRW2515 AND MRW3015
• Device Catalogue Number: MRW2515 AND MRW3015
• Device Lot Number: PM00017365 AND PM00017366
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1