MAUDE Adverse Event Report: NOA MEDICAL INDUSTIRES NOA MEDICAL INDUSTRIES; SIDE RAIL SET - HEAD - BEHAVIORAL HEALTH BED (GRAY)

Model Number	7540209LGRY
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In house investigation found a slight tolerance issue on the frames that allowed the latch attachment pins to move, catching the button on the cover and either breaking it or hanging up on the cover and getting stuck.Button was attached to the latch with plastic pins that broke easily.The red button was redesigned to shorten and be held in place with screws instead of pins.Changed latch attachment pins to a threaded rod and plates which secures the latch to prevent movement.Pin length on the back of the latch was also found to affect performance.Customer was sent new design.A correction is planned to replace frame assembly (frame, latch, red button).
Event or Problem Description
(b)(4), customer reported issue with the right-side head side rail.When pressing the release button, the side rail gets stuck.There is a metal piece that needs to retract when pushing the red button, but it does not retract completely, and that is why the siderail gets stuck.Device was not returned for investigation.Side rail is part of the bed package.There are no problems with the bed itself.Report is being filed after the 30 day timeframe due to confusion regarding the filing of mdrs with little information.We are reporting the information reasonably known to us out of an abundance of caution.

• Brand Name: NOA MEDICAL INDUSTRIES
• Common Device Name: SIDE RAIL SET - HEAD - BEHAVIORAL HEALTH BED (GRAY)
• Manufacturer (Section D): NOA MEDICAL INDUSTIRES; 801 terry ln; washington MO 63090
• Manufacturer (Section G): NOA MEDICAL INDUSTRIES; 801 terry ln; washington MO 63090
• Manufacturer Contact: karen coke ; 801 terry ln; washington, MO 63090 ; 6362397600
• MDR Report Key: 21092230
• Report Number: 1931947-2024-00002
• Device Sequence Number: 12925950
• Product Code: FNL
• UDI-Device Identifier: 00817492012745
• UDI-Public: 00817492012745
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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: 7540209LGRY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown