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

Model Number	8021
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reporting a complaint on product 8021 filler cushions.Customer states that the ifu recommends using 8021 when a patient requires tube feeding to raise the head of the bed.While using the product for this purpose the cushion doesn't work and ends up falling on the customer's head over time.There has been distributor feedback that confirms the filler cushion will not stay in place.
Additional Manufacturer Narrative
H3 product was not returned for evaluation.Therefore, this report is based solely on the information provided by the customer.A device history review could not be performed due to lot information not provided.A recreation of the reported issue was performed and the customer's experience could not be recreated.A review of the complaint database did not reveal any similar events against this issue in the past two years.Therefore, it appears this complaint was an isolated event.The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.The ifu states make sure that both filler cushions are securely in place and cannot be removed by the patient and that the patient cannot crawl under or around the posey filler cushions.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 warning 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).

• Brand Name: POSEY BED FILLER CUSHION
• 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: 18852047
• Report Number: 2182318-2024-00015
• Device Sequence Number: 20704354
• Product Code: OYS
• UDI-Device Identifier: 10190676000552
• UDI-Public: 10190676000552
• 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): 02/06/2024

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: 8021
• Device Catalogue Number: 8021
• 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: 02/06/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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