MAUDE Adverse Event Report: Medline ReNewal MEDLINE CO-LABEL; 401904 @DIAGNOSTIC EP CAT, STEERABLE, SU

Catalog Number	401904RH
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "plugged in and wasn¿t receiving signal from certain pins.".
Additional Manufacturer Narrative
The issue reported was "wasn¿t receiving signals from certain pins." the devices were returned to innovative health for investigation, and the investigation process included review of the original manufacturing records, evaluation of the device, visual inspection, and electrical testing; no observations were noted during the manufacturing-record review, and the devices passed all approved testing and inspections during the manufacturing process.For this complaint, the device received by innovative health was different than the one reported; no additional details were provided, therefore the investigation was completed for the returned device, and the provided record does not state that the reported problem was confirmed.The cause was documented as "dc:unknown responsible party - mishandling: by mfg.Or can't determine," corrective action type was none, and medline renewal trends and monitors all complaints with further investigation and/or corrective action as applicable based on trending results.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE CO-LABEL
• Common Device Name: 401904 @DIAGNOSTIC EP CAT, STEERABLE, SU
• Manufacturer (Section D): Medline ReNewal; 1500 ne hemlock avenue; redmond OR 94456 -187
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50873050
• Report Number: 3032391-2026-00154
• Device Sequence Number: 21511611
• Product Code: NLH
• UDI-Device Identifier: 10888277407602
• UDI-Public: 10888277407602
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K221067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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 Catalogue Number: 401904RH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown