• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RHYTHMLINK INTERNATIONAL, LLC. MRW2515, MRW3015 & MRSPSS8015; MR CONDITIONAL ELECTRODES Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18642395
MDR Text Key334568852
Report Number1067162-2024-00001
Device Sequence Number1
Product Code GXY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 NumberMRW2515, MRW3015 & MRSPSS8015
Device Catalogue NumberMRW2515, MRW3015 & MRSPSS8015
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/28/2023
Initial Date FDA Received02/05/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
-
-