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

Model Number	8070
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 the product is scheduled to be returned but has not been received in by the manufacturer 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.A device history record (dhr) of the affected lot number did not reveal any issues that could have contributed to the reported incident.Being that the unit is already more than one year old since it was manufactured, it is unlikely that a manufacturing non-conformity contributed to the reported issue, and the likely cause of the event is abnormal use or normal wear and tear.The instructions for use are adequate in providing clear and concise warnings against putting a damaged canopy into use with a patient.The instructions states 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.In this case, it is unknown the type of damage.Without the return of the device this particular complaint cannot be confirmed, it can be speculated that the damage was the result of routine wear-and-tear.Manufacturer reference file: (b)(4).
Event or Problem Description
Sn (b)(6) zipper is broken.

• 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: 21019295
• Report Number: 2182318-2024-00170
• Device Sequence Number: 9155774
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/26/2024

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: 8070
• Device Catalogue Number: 8070
• 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: 11/26/2024
• Initial Report FDA Received Date: 12/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2021
• 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