MAUDE Adverse Event Report: TIDI PRODUCTS LLC REPLACEMENT NURSE CALL CABLE; MONITOR, BED PATIENT

Model Number	8282
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 the report is based solely on the information provided by the customer.The tm provided information from a meeting held with the facility regarding the complaint issue.During the meeting, it was determined that the nurse call cord was worn due to normal wear and tear over the years.The nurse call cord was tested as per our instructions and warnings to test all equipment prior to leaving patient.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states when using a nurse call cable, ensure the nurse call cable is plugged in to both the alarm and the wall jack before leaving the patient unattended.Verify that an alert is received at the nursing station if the cable is unplugged from the wall jack.Note: there will be no alert at the nursing station or at the bedside if the nurse call cable is unplugged from the alarm.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file (b)(4).H3 other text: product not returned.
Event or Problem Description
Customer reported issue with nurse call cord not working to ring out to nurse call system.The issue is isolated to one unit reporting random occurrences.The customer and facility engineer conducted initial testing to determine that the nurse call cord was not working properly.

• Brand Name: REPLACEMENT NURSE CALL CABLE
• Common Device Name: MONITOR, BED PATIENT
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 19997648
• Report Number: 2182318-2024-00103
• Device Sequence Number: 4374513
• Product Code: KMI
• UDI-Device Identifier: 10190676002044
• UDI-Public: 10190676002044
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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 Model Number: 8282
• Device Catalogue Number: 8282
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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