MAUDE Adverse Event Report: TIDI Products LLC 8070 TENT AND FRAME; Patient Bed With Canopy/Restraints

Model Number	A8070TF
Medical Device Problem Codes	Mechanical Problem (1384); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was thrashing around in the posey bed and the side panel popped open at the zipper.It also caused a tear in the seam.When side panel became unsecure the patient began to fall out of the bed no harm was reported to the patient.Clincians believe incident was a direct result of patient using excessive force inside the enclosure bed.
Additional Manufacturer Narrative
The product has been received and is scheduled to be evaluated but evaluation has not been completed at the time of this report.Therefore, this event is reported based on the information provided by the customer.Confirmation of the customer's complaint and the root cause could not be determined.Posey beds are multi-use items.As such, it is anticipated that the units may experience wear over time, and as part of standard care the beds should be inspected prior to use.If damage is noted during these routine bed inspections, the unit should not be put into use with a patient and should be replaced.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Service issues are trended and reviewed by management on a monthly basis.As part of this monthly review, trends and excursions above control limits will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.Manufacturer reference file: (b)(4).

• Brand Name: 8070 TENT AND FRAME
• Common Device Name: Patient Bed With Canopy/Restraints
• Manufacturer (Section D): TIDI Products LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; +1(920)751-4300
• MDR Report Key: 50787880
• Report Number: 2182318-2026-00096
• Device Sequence Number: 18774059
• Product Code: OYS
• UDI-Device Identifier: 10190676000996
• UDI-Public: 10190676000996
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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: A8070TF
• Device Catalogue Number: A8070TF
• Device Lot Number: 2020110615
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• 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: 08/17/2026
• Supplement Date Received by Manufacturer: 09/21/2026
• Initial Report FDA Received Date: 09/16/2026
• Supplement Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown