MAUDE Adverse Event Report: JOERNS HEALTHCARE PANACEA 1000 BED; PATIENT BED

Model Number	PANACEA 1000-FLEX
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Fall (1848)
Date of Event	07/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report or other information submitted by joerns healthcare under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that customer reached out regarding the beds.They have 8 and "really like them but are concerned" initial report: a resident tried to use the foot board to steady himself but the footboard brackets just popped out of the slot and the panel flipped then the resident fell.According to the don, he needed 21 stitches in his knee.The resident's weight is 148.4 lbs.Customer needs to know if there is some way to lock down the footboards so they do not pop out of the brackets." the bed yall sold us, they found the foot rest and headboard have a bracket, it slides into a slot." resident apparently used it to brace to get up.When they put weight against it, the footboard tilted sideways and the resident fell.They need something that will secure the footboard into the bed, we cannot have that happen again."he knows they are not supposed to use it to get up but -it will happen again- if they don't change something." complaint #(b)(4) has been entered into our system.

• Brand Name: PANACEA 1000 BED
• Common Device Name: PATIENT BED
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bsy ; avenida pedro hinojosa no. 26; ciudad industrial; matamoras, tamaulipas 87499 ; MX 87499
• MDR Report Key: 22824546
• Report Number: 3009402404-2025-00029
• Device Sequence Number: 21196807
• Product Code: FNL
• UDI-Device Identifier: 00810055883066
• UDI-Public: 00810055883066
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: PANACEA 1000-FLEX
• Device Catalogue Number: PANACEA 1000-FLEX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 08/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 67 KG