MAUDE Adverse Event Report: TIDI PRODUCTS, LLC ALARM SENSOR, 30-DAY BED SENSOR PAD; MONITOR, BED PATIENT

Model Number	8283
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
We received a fda medwatch complaint on product # 8283 from unknown user.It is stated that a posey bed alarm was placed on a trauma patient and the alarm did not sound when the patient tried to exit the bed.This resulted in a fall from the bed.It is designated as a serious injury.The reporter has decided to remain anonymous.Date of the report is (b)(6) 2023.Reported initially by brenda ammonette reg/comp manager.920-279-7744 or e-mail at bammonette@tidiproducts.Com.Lot # 2144t217.Information given was extremely limited.
Additional Manufacturer Narrative
The tidi regulatory compliance manager received an email from the fda original letters stating that the fda received a medical device report from a reporter who elected not to be identified concerning the tidi 8283 bed sensor pad.This event is reported solely on the medwatch information provided by the fda.An investigation of similar complaints revealed several potential causes, including damages 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.A device history record (dhr) of the affected lot number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The unit passed all verification testing and met manufacturing specifications prior to being released for distribution.Without the return of the device reported issue could not be confirmed.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 number 2023-00348 mdr report number mw5114480.

• Brand Name: ALARM SENSOR, 30-DAY BED SENSOR PAD
• 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: 16811821
• Report Number: 2182318-2023-00030
• Device Sequence Number: 20351694
• Product Code: KMI
• UDI-Device Identifier: 10190676004376
• UDI-Public: 10190676004376
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8283
• Device Catalogue Number: 8283
• Device Lot Number: 2144T217
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown