MAUDE Adverse Event Report: RHYTHMLINK INTERNATIONAL, LLC. MRW2515, MRW3015 & MRSPSS8015; MR CONDITIONAL ELECTRODES

Model Number MRW2515, MRW3015 & MRSPSS8015

Device Problem Material Separation (1562)

Patient Problem Choking (2464)

Event Date 01/01/2023

Event Type  Injury  

Event Description

The user did not state that an adverse event or patient harm occurred but stated that the loose heat shrink can be hazardous in the pediatric setting.The user was unable to provide the part number or lot number, but we identified the potential part numbers based on distribution history.The user was also unable to provide dates the loose heatshrink was noticed but confirmed it was noticed within the year 2023.The information was reported by a customer on the annual customer satisfaction survey.

• Brand Name: MRW2515, MRW3015 & MRSPSS8015
• Type of Device: MR CONDITIONAL ELECTRODES
• Manufacturer (Section D): RHYTHMLINK INTERNATIONAL, LLC.; 1140 1st street south; columbia SC 29209
• Manufacturer (Section G): RHYTHMLINK INTERNATIONAL, LLC; 1140 1st street south; columbia SC 29209
• Manufacturer Contact: sandra o'reilly ; 1140 1st street south; columbia 29209 ; 8032521111
• MDR Report Key: 18642395
• MDR Text Key: 334568852
• Report Number: 1067162-2024-00001
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/01/2024

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: MRW2515, MRW3015 & MRSPSS8015
• Device Catalogue Number: MRW2515, MRW3015 & MRSPSS8015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 02/05/2024
• 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
• Patient Outcome(s): Other