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 unit was returned for evaluation.Visual findings observed that the unit was received with an 8282 nurse call cable with a sn (b)(6).The front side of the unit has been labeled patient fall and has a red miniature device attached closer to the bottom end.Scratches and indentations observed on the exterior housing of the unit.The unit compartment has signs of previous battery corrosion such as white powder residue at the side wall, and upper end of the compartment.Pin 3 inside the nurse call receptacle was bent down.The nurse call cable was labeled intermittent.Evaluation found the nurse call cable is functional and will perform as intended when evaluated with an in-house 8645 unit and dmm (digital multi-meter).However, the unit did not send a signal to activate the light at the nurse call test fixture when pressure was removed from the sensor pad simulator due to battery leakage/corrosion on the pcba (printed circuit board assembly).Additionally, when the nurse call cable was plugged into the nurse call receptacle, the unit played the audio cue between nurse call attached and nurse call detached repeatedly when the cable was moved by hand due to a bent pin 3 inside the nurse call receptacle.Being that the alarm is already more than three years old since it was manufactured, it is unlikely that a manufacturing non-conformity contributed to the nurse call issue, and it is likely that the cause of the event is by storing the unit for extended period with batteries inside the compartment, normal wear-and-tear, severe shock, and other effects of repeated use over time.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).
Event or Problem Description
Customer reporting a complaint on product # 8645 & 8282.Customer states the products were in use and did not trigger the nurse call system when a patient got up from their chair.This resulted in a fall.No injuries were reported.

• 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: 19083185
• Report Number: 2182318-2024-00049
• Device Sequence Number: 7621087
• Product Code: KMI
• UDI-Device Identifier: 10190676002044
• UDI-Public: 10190676002044
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/15/2024

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: 560-200901-0410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2020
• 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