MAUDE Adverse Event Report: GRAPHIC CONTROLS ACQUISITION CORP.DBA NISSHA MEDIC TENDERTRODE PLUS; ELECTRODE, ELECTROCARDIOGRAPH

Model Number	A10055-SRT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple events have occurred: telemetry leads not functioning, upon observation it was noted that one of the leads (black) became disconnected from sticker.Also was noted that the other 2 leads (white and green) had some separation/peeling on stickers and loosening of wires but not yet completely disconnected.Leads were removed and provided to the clinical nurse specialist in several incidents.[date redacted] telemetry leads not functioning, upon observation it was noted that one of the leads (black) became disconnected from sticker.Also was noted that the other 2 leads (white and green) had some separation/peeling on stickers and loosening of wires but not yet completely disconnected.Leads were removed from patient and bagged, given to cns [clinical nurse specialist].[date redacted] the wire came separated from lead lot #102624 [date redacted] the wire separated from the lead.Lot number #102624 [date redacted] white lead of ekg [electrocardiogram] leads, wire disconnected from under sticker, so central monitor was alarming.Baby's feed at breast had to be paused to put on a new sticker.[date redacted] ecg [electrocardiogram] wire came apart from the gel adherence pad.[date redacted] the black lead wire pulled out from under sticker.Baby had to be unwrapped and woken up from being asleep to replace lead.[date redacted] vermed neonatal cardiac lead, wire separated from the lead.

• Brand Name: TENDERTRODE PLUS
• Common Device Name: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): GRAPHIC CONTROLS ACQUISITION CORP.DBA NISSHA MEDIC; 400 exchange st; buffalo NY 14204
• MDR Report Key: 22478411
• Report Number: 22478411
• Device Sequence Number: 15589478
• Product Code: DRX
• UDI-Device Identifier: 10813150021651
• UDI-Public: (01)10813150021651
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/18/2025
• Report Date (Section F): 06/18/2025

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: A10055-SRT
• Device Catalogue Number: A10055-SRT
• Device Lot Number: 102624
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/18/2025