MAUDE Adverse Event Report: TIDI PRODUCTS LLC DISPOSABLE CHAIR ALARM BELT LONG; MONITOR, BED PATIENT

Model Number	8399L
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based solely on the information provided by the customer.Due to product not being returned, reported issue cannot be determined with only the information available.Historical review of the complaint database revealed similar instances where the belt ripped at the seams.Of those complaints returned for evaluation, investigations revealed user error as the foam materials of the returned sensor belts were being torn apart due to excessive force.Additionally, a review of the complaint database of complaints for 8645 alarms either sounding when they shouldn¿t or not sounding when they should.Investigations into these complaints revealed that the most likely cause of the reported complaint is either damage to the sensor receptacle or damage to the rj-11 clip.Damage can cause the pins inside the sensor receptacle to become stuck down, either triggering no alarm or false alarm.It can also cause the sensor cable to not have a secure fit in the receptacle, which can allow movement to affect function.Likewise with damage to the sensor cable clip.Other causes, such as corrosion and moisture damage, are also a possibility.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 check that alarm is on and that sensor belt/alarm system is working properly each time before leaving patient unattended.Pull first yellow strap to activate alarm then connect for monitoring.Stop use at once if alarm fails to sound.Before leaving the patient unattended, explain the purpose for the belt.Make sure the patient understands: the need to call for assistance before exiting the chair; and how to self -release.Ensure all parts of the system are operational before leaving patient unattended.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 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 reported earlier in the month, in the first week of june, we had two instances where we found patients out of their seatbelts, but the alarms were not sounding.Upon review we found that the belts were torn, at what appears to be a seam.Neither belt was tight or mounted in an unusual way.1st belt: lot #3304t084.2nd belt: lot #4059t038.Then, a week later (6/12), we had a patient fall.The patient had removed their seatbelt, the alarm sounded briefly and then stopped.Our nurse manager and therapy manager assessed the box and out of 4 attempts to trigger the alarm, it only worked properly once.Belt lot #3304t084.
Additional Manufacturer Narrative
H3 product was returned and evaluated.Visual findings observed two sensor belts returned with the same lot number.The first sensor belt reviewed has the inner, secondary blue connection point torn off.The second sensor had no visual findings to report.Evaluation found each time the belts were fastened, the alarm correctly entered monitoring state.As soon as the belts were released, the alarm sounded a continuous alert.Both belts were found to pass all functional testing and functioned as intended.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 check that alarm is on and that sensor belt/alarm system is working properly each time before leaving patient unattended.Pull first yellow strap to activate alarm then connect for monitoring.Stop use at once if alarm fails to sound.Before leaving the patient unattended, explain the purpose for the belt.Make sure the patient understands: the need to call for assistance before exiting the chair; and how to self -release.Ensure all parts of the system are operational before leaving patient unattended.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 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
Supplemental medwatch being sent for additional information.

• Brand Name: DISPOSABLE CHAIR ALARM BELT LONG
• 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: 19833192
• Report Number: 2182318-2024-00091
• Device Sequence Number: 7504403
• Product Code: KMI
• UDI-Device Identifier: 10190676006288
• UDI-Public: 10190676006288
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 8399L
• Device Catalogue Number: 8399L
• Device Lot Number: 3304T084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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