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

Model Number	7540228LGRY
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4), on tue, dec 5, 2023 at 9:41am we received an email alleging that the red button on the side rail that releases the rail to drop down was stuck inside and doesn't pop out as it should to lock the rail in place.The rail isn't locking into place, which allowed him to fall out of his bed due to the rail dropping from the upright position.Fortunately, he is okay but the rail is not.Incident was reported from a user via a distributor, no other information was provided.We sent a replacement with a return label so the device could return for investigation.We reached out again later when the part had not returned offering to send another return label but never heard back from the customer.We could not determine that a malfunction occured.Report is being filed after the 30 day timeline due to confusion over the filing of mdrs with little information.We are reporting with the information reasonably known to us out of an abundance of caution.Side rail is part of the bed package.There are no problems associated with the bed itself.
Additional Manufacturer Narrative
The latch is a two step process where the button must be pushed in and the side rail moved.There is a possibility that they didn't get the side rail pushed all the way up to cause the button to pop out and the rail to lock into place.A replacement was sent to the customer.We were waiting for the part to retun including contacting twice and sending a return label.Device was not returned for inspection so a malfunction could not be determined.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.A correction is planned to replace frame assembly (frame, latch, red button).

• Brand Name: NOA MEDICAL INDUSTRIES
• Common Device Name: SIDE RAIL SET - FOOT BEHAVIORAL HEALTH BED (GRAY)
• Manufacturer (Section D): NOA MEDICAL INDUSTRIES; 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: 21091763
• Report Number: 1931947-2023-00002
• Device Sequence Number: 21066499
• Product Code: FNL
• UDI-Device Identifier: 00817492012745
• UDI-Public: 00817492012745
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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
• Operator of Device: Health Professional
• Device Model Number: 7540228LGRY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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: Male