MAUDE Adverse Event Report: TIDI PRODUCTS LLC POSEY BED 8070 TENT AND FRAME; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number	A8070TF
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states that their customer had a patient who fell out of the enclosed bed.The patient was able to penetrate the zipper tract near at bottom part of panel with all clips/buckles engaged.
Additional Manufacturer Narrative
The product has not been received 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, serviceable items.As such, it is anticipated that the units may occasionally require repair, 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 returned to posey for servicing.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Complaints 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#: (b)(4).
Additional Manufacturer Narrative
A device return was requested for evaluation; however, the customer conducted their own assessment and reported finding no defect with the canopy.Despite our recommendation to remove the device from use until it could be evaluated by the manufacturer, the product was sent to another facility and is currently in use.As a result, the manufacturer was unable to conduct an evaluation.The initial report was submitted based solely on the event description provided.No additional information has been received that would impact the reportability determination at this time.This follow-up is being submitted to document the updated status of the investigation.Manufacturer reference#: (b)(4).Medwatch reference#: (b)(4).
Event or Problem Description
The initial complaint described a patient breaching the zipper tract of the canopy near the bottom panel, despite all clips and buckles being engaged.This follow-up provides updated investigation information.

• Brand Name: POSEY BED 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 ; 9207514300
• MDR Report Key: 22310018
• Report Number: 2182318-2025-00061
• Device Sequence Number: 7997418
• Product Code: OYS
• UDI-Device Identifier: 10190676000996
• UDI-Public: 10190676000996
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: A8070TF
• Device Catalogue Number: A8070TF
• Was Device Available for Evaluation?: No
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2019
• 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