MAUDE Adverse Event Report: NOA MEDICAL INDUSTRIES PANACEA; BED 3500 MAH

Model Number	1070014BEI
Medical Device Problem Codes	Human-Device Interface Problem (2949); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report will be updated as information becomes available.Reporting with information reasonably known.
Event or Problem Description
(b)(4).At 3:23 pm on (b)(6)2024, (b)(6) called to report an incident that allegedly involved the following product or device: bed.(b)(6) reported that the following occurred: (b)(6) said she was told the resident said they got whiplash when the head of the bed gave out.It is unknown how many people were present during the incident.The initial report was received and staff left 3 messages and she had not called back by thurs.(b)(6)2024 9:38am.On (b)(6)2024 10:47am we were notified of the incident and that they were able to contact her.The response was that maintenance fixed the issue but didn't know how it was possible to come out of the track.She is a bariatric patient weight is 396 lbs.They did not report that she was taken for treatment or provide any medical records for the alleged whiplash.No pictures or videos were provided.There was little response from the customer so we sent a replacement bed and requested the bed in question be returned for investigation.At the time of this report, the bed has not returned for investigation and could not determine if it malfunctioned.Report is being filed after the 30 day timeline due to confusion regarding the reporting of mdrs with little information.We are reporting with the information reasonably known to us out of an abundance of caution.
Additional Manufacturer Narrative
Multiple tests were completed with the maximum safe working load of 600 lbs.To simulate what could have happened.The only way testing could get the bed to fail in the manner described was to strap the caster base to the head end of the bed to simulate the bed raising until it hit an obstruction.The bed would stop and the operator would have had to repeatedly push the up elevation button to get it to move again resulting in bending the actuator pin, arm and leg which resulted in pulling the legs out of the track and the head end of the bed collapsing.The customer was advised of test results and to look for obstructions that could be in the room.Watch for the bed stopping or only moving at one end indicating there is an obstruction.Scratches under the bed indicate a lift was used or storage was under the bed.Do not store items under the bed.

• Brand Name: PANACEA
• Common Device Name: BED 3500 MAH
• 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: 21093248
• Report Number: 1931947-2024-00001
• Device Sequence Number: 8934554
• Product Code: FNL
• UDI-Device Identifier: 00817492011618
• UDI-Public: 00817492011618
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Replace
• Type of Report: Initial,Followup
• 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: 1070014BEI
• Device Catalogue Number: C7570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 180 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White