MAUDE Adverse Event Report: TIDI PRODUCTS LLC KEEPSAFE DELUXE; FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED

Model Number	8374
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned even after multiple attempts; however, the customer provided pictures of the alarm in question.This event is reported solely on the information provided by the customer.A review of the images provided by the customer shows surface scratches and sticky residue on the exterior housing as signs of normal wear and tear.The image of the sensor receptacle has bent connector pins inside that may have contributed to reported issue for not functioning properly.This could be caused by removing the sensor connector rj-11 of the sensor pad without pushing on the release tab, by stretching the sensor cable such as the cable being caught with a bed mechanism or heavy equipment, or by inserting a foreign object into the sensor receptacle causing the connector pins inside to be bent.Being that the unit is four years old since it was manufactured, it is unlikely that manufacturing non-conformity contributed to the reported complaint, and the most probable cause is normal wear and tear.An investigation of similar complaints revealed several potential causes, including damage to either the alarm sensor receptacle or the sensor rj-11 clip.Damage to the sensor receptacle can cause the pins inside to become stuck down, either triggering no alarm or false alarm.It can also cause the sensor cable to not have a secure fit with the receptacle, allowing for movement to affect the function.Likewise, with damage to the sensor cable clip.Other causes, such as corrosion and moisture damage, are also a possibility.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 warning 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 states that the alarm is malfunctioning.The alarm does not consistently sense when weight is removed from a sensor pad.It will sometimes blink red and then sometimes green.Batteries have had intermittent issues.

• Brand Name: KEEPSAFE DELUXE
• Common Device Name: FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED
• 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: 17889209
• Report Number: 2182318-2023-00093
• Device Sequence Number: 17877197
• Product Code: PJO
• UDI-Device Identifier: 10190676002143
• UDI-Public: 10190676002143
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/08/2023

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: 8374
• Device Catalogue Number: 8374
• Device Lot Number: 1942KE0489
• 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: 09/08/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2019
• 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