MAUDE Adverse Event Report: TIDI PRODUCTS LLC POSEY BED 8060; PATIENT BED WITH CANOPY/RESTRAINTS

Model Number	8060
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 evaluation of the canopy found a zipper that does not engage correctly in a patient access area.A zipper that does not engage correctly may allow the zipper to be initially closed.A patient can later open the zipper by applying pressure to the zipper at the location of the misaligned zipper elements (teeth).In this case, there was no impact or consequence to the patient and the canopy was returned for servicing when the zipper issue was identified.Although it cannot be confirmed, it is possible that routine wear-and-tear from repeated use contributed to the zipper damage.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.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).
Event or Problem Description
S/n (b)(6) has zipper damage, zipper splitting right side panel.

• Brand Name: POSEY BED 8060
• 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: 21536637
• Report Number: 2182318-2025-00020
• Device Sequence Number: 7643107
• Product Code: OYS
• UDI-Device Identifier: 00618125192250
• UDI-Public: 00618125192250
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/04/2025

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: 8060
• Device Catalogue Number: 8060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2018
• 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