MAUDE Adverse Event Report: TIDI PRODUCTS LLC FLOOR CUSHION, BEVELED GLOW; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number	6027R
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 an investigation has been completed regarding the complaint of floor cushions sliding on the floor.An attempt to recreate the complaint further confirms the product delivered the intended use of the floor cushion, and slippage did not occur.The manufacturing team reviewed the product and confirmed that there were no anomalies during production.Our results confirm the floor cushions have met all specifications.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states inform resident and staff to take care when stepping on or off of the cushion to avoid tripping.Follow your facility¿s procedures for cleaning spills in patient care areas.Do not place floor cushions on or around damp or wet areas.Clean spills on, around or under floor cushions.Liquids under floor cushions may cause a slip and fall accident.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.Manufacturer reference file (b)(4).
Event or Problem Description
Customer reported complaint regarding product part 6027r sliding on the floor.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: FLOOR CUSHION, BEVELED GLOW
• Common Device Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: 19702833
• Report Number: 2182318-2024-00082
• Device Sequence Number: 7674215
• Product Code: FNL
• UDI-Device Identifier: 10190676000873
• UDI-Public: 10190676000873
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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: 6027R
• Device Catalogue Number: 6027R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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