MAUDE Adverse Event Report: NOA MEDICAL INDUSTRIES DIRECT SUPPLY; BED - PAN3500, MAH W/SAFETY LOCK - 80-84" X 35-42" (BEIGE)

Model Number	1070014BEI
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the arm with the wheel on it became separated from the frame, causing the head of the bed to come crashing down.Customer did not report a patient in the bed.We are sending a new leg and requesting the leg in question be returned for investigation to determine if a malfunction occured.We are reporting with the information provided out of an abundance of caution.
Additional Manufacturer Narrative
Leg returned for evaluation.Leg is bent with one leg higher than the other which pulls the leg inward making the nlyon roller ride on the edge of the channel and/or travel down the channel at an angle creating a wear spot on the roller.Leg could be bent due to possible overloading or hanging up on something such as a windowsill, furniture in the room, visitor sitting on the bed, lowering bed down on something under the bed, using a lift that did not offer enough clearance and hitting the leg, etc.Causing the leg to bend.Leg had marks on the inside and outside edge under the legs indicating it had been possibly been hit from the side, rubbed or scuffed underneath or fell onto something that was under the bed.Previous testing found the only way we could recreate the leg coming out of the channel was if the bed was loaded with maximum weight, had a bent arm and bent leg and it was prevented from moving up and the up button continued to be pressed thus bending the leg and forcing it out of the channel.Report filed 2/14/25, found on 3/27/25 during follow up reporting that the original report was not recieved.This report encompasses the inital and follow up report.
Event or Problem Description
Customer reported the arm with the wheel on it became separated from the frame, causing the head of the bed to come crashing down.Customer did not report a patient in the bed.We are sending a new leg and requesting the leg in question be returned for investigation to determine if a malfunction occured.We are reporting with the information provided out of an abundance of caution.
Additional Manufacturer Narrative
Leg returned for evaluation.Leg is bent with one leg higher than the other which pulls the leg inward making the nlyon roller ride on the edge of the channel and/or travel down the channel at an angle creating a wear spot on the roller.Leg could be bent due to possible overloading or hanging up on something such as a windowsill, furniture in the room, visitor sitting on the bed, lowering bed down on something under the bed, using a lift that did not offer enough clearance and hitting the leg, etc.Causing the leg to bend.Leg had marks on the inside and outside edge under the legs indicating it had been possibly been hit from the side, rubbed or scuffed underneath or fell onto something that was under the bed.Leg was installed on a bed and maximum weight (safe working load) was placed on the bed and tested for 7 days.We could not recreate the leg coming out of the channel.Previous testing found the only way we could recreate the leg coming out of the channel was if the bed was loaded with maximum weight, had a bent arm and bent leg and it was prevented from moving up and the up button continued to be pressed thus bending the leg and forcing it out of the channel.Report filed (b)(6) 2025, found on (b)(6) 2025 during follow up reporting that the original report was not received.This report encompasses the initial and follow up reports.

• Brand Name: DIRECT SUPPLY
• Common Device Name: BED - PAN3500, MAH W/SAFETY LOCK - 80-84" X 35-42" (BEIGE)
• 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: 21708862
• Report Number: 1931947-2025-00001
• Device Sequence Number: 4745654
• Product Code: FNL
• UDI-Device Identifier: 00817492011618
• UDI-Public: 00817492011618
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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
• Operator of Device: Health Professional
• Device Model Number: 1070014BEI
• Device Catalogue Number: C7570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2024
• 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