MAUDE Adverse Event Report: TIDI PRODUCTS LLC WIRELESS NURSE CALL ADAPTER; MONITOR, BED PATIENT

Model Number	8282WL
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 investigation into the returned products did not confirm the reported issues.Visual findings observed the fall monitor and wireless nurse call adapter both being received with batteries inside.Product was not returned for 8309wl as it was discarded by customer.The returned fall monitor unit was evaluated with the returned wireless nurse call adapter and an in-house wireless sensor pad.The unit was tested by simulating use.It functioned as expected, passing all functional tests.No physical damage was observed on either the fall monitor nor the wireless nurse call adapter.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 if the alarm and/or sensor do not function properly, remove the alarm and sensor from service and replace them with a properly functioning alarm and/or sensor.Do not use the alarm or sensor if it does not activate each time weight is removed from the sensor, or if the chair belt sensor is unfastened.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.All complaints are trended and reviewed by management on a monthly basis.As a part of the 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 #'s 8645wl, 8282wl, & 8309wl.Customer states that a fall occurred with no alarm sounding.When the staff tested the alarm they noticed that it would pair and then detach without sounding an alarm or voice/noise sounding.The pad was not kept & was discarded.

• Brand Name: WIRELESS NURSE CALL ADAPTER
• 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: 19370586
• Report Number: 2182318-2024-00067
• Device Sequence Number: 7703227
• Product Code: KMI
• UDI-Device Identifier: 10190676007643
• UDI-Public: 10190676007643
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 04/26/2024

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: 8282WL
• Device Catalogue Number: 8282WL
• Device Lot Number: 2249KQ0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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