MAUDE Adverse Event Report: TIDI PRODUCTS LLC SITTER ON CUE PRO; MONITOR, BED PATIENT

Model Number	8645WL
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported situation with posey on cue pro 8645wl sn unknown.Chair alarm did not alert staff when battery was low / about to die.Background: fairmont m/s patient admitted to room 218 on (b)(6) 2024, late afternoon.On (b)(6) 2024 @ 0700 rn set up the chair alarm as patient would be getting to the chair in the morning.No issues with set up per rn.At 0900 the patient attempted to get out of chair and alarm did not sound.When rn went in room, the battery light upper right hand corner of alarm was red, meaning battery low/dead.Assessment per nursing staff, the posey alarm typically provides a verbal cue / message that battery is low.This did not occur at 0700 when rn set up chair alarm.
Additional Manufacturer Narrative
The report is based solely on the information provided by the customer.No serial number was provided; therefore, the dhr for this alarm cannot be reviewed.Customer confirmed patient did not sustain any injuries as a result of this incident.Without the return of the device, the reported issue could not be confirmed.A review of the complaint database revealed 4 other events similar to the reported issue in the past two years.Product was not returned for two of the complaints, therefore, root cause could not be determined.Of the products returned, units were found to pass all functional testing and met specification.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).

• Brand Name: SITTER ON CUE PRO
• 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: 20196889
• Report Number: 2182318-2024-00116
• Device Sequence Number: 20536986
• Product Code: KMI
• UDI-Device Identifier: 10190676007636
• UDI-Public: 10190676007636
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 08/12/2024

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: 8645WL
• Device Catalogue Number: 8645WL
• 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: 08/12/2024
• Initial Report FDA Received Date: 09/11/2024
• 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