MAUDE Adverse Event Report: TIDI PRODUCTS LLC POSEY BED 8070; 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
Additional Manufacturer Narrative
The product is not being returned; therefore, this evaluation is based solely on the information provided by the customer.Without a serial or lot number, the age of the unit cannot be determined, and a device history record (dhr) review could not be completed.The customer's report does not indicate a manufacturing defect with the zipper.It was reported that the facility was using the bed on a toddler who was under the weight and height requirement for use of this device.They were using the netted bed to protect the toddler from banging head on the crib rails post op.The customer had reached out in an attempt to obtain education on the proper use of the bed.The instructions for use are adequate in providing clear and concise warnings for using the device.Per the contraindications: "the posey bed is not intended for use with patients who weigh less than 46 pounds or are shorter than 46 inches.These patients are at risk of serious injury or death, and the posey bed has not been tested for use by such patients." additionally, the instructions state: "warning, never use the posey bed if there is damage to the canopy, access panels or zippers.A failure to heed this warning may result in patient escape or unassisted bed exit, which may lead to serious injury or death from a fall.Always check the canopy and the zippers before leaving the patient unattended to help reduce the risk of a fall or unassisted bed exit.Never leave a patient unattended if the zippers do not close securely, there are holes in the canopy or netting, the foam padding covering the metal frame is damaged or missing, or the frame is damaged." the posey bed is a serviceable, multiple use item.As such, some wear-and-tear is expected.The posey bed user manual is explicit in advising the customer to inspect for any missing or damaged components prior to use with a patient, and to not use the unit if any damage is found.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 warnings 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.Manufacturing reference file#: (b)(4).
Event or Problem Description
Customer reported an incident with the posey bed where a toddler was found on the floor outside of the bed enclosure due to an unsecured zipper.The toddler or any staff did not suffer any injuries in the related event.

• Brand Name: POSEY BED 8070
• 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: 22378766
• Report Number: 2182318-2025-00065
• Device Sequence Number: 9315005
• Product Code: OYS
• UDI-Device Identifier: 10190676000996
• UDI-Public: 10190676000996
• 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
• Report Date (Section B): 06/02/2025

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
• 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: 06/02/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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