MAUDE Adverse Event Report: JOERNS HEALTHCARE BARI10A; PATIENT BED

Model Number	BARI10A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to the manufacturer, by the end user, per the end user, that per operations supervisor hospital, the transporter was trying to put the right side of the bed up.He was not able to lock the side rail into place due to the mattress being inflated and the side extenders not being extended.It did make it hard to lock into place.At that time, the transporter was struck in the head by the side rail.He was bent down, and the side rail dropped and struck him causing him to go to the emergency room for treatment.At the time, the transporter was not a patient, but after the incident he did become one.Complaint (b)(4) was entered into our system.
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.

• Brand Name: BARI10A
• 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: 22627011
• Report Number: 3009402404-2025-00026
• Device Sequence Number: 9251226
• Product Code: OSI
• UDI-Device Identifier: 00857268006011
• UDI-Public: 00857268006011
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2025

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: Other
• Device Model Number: BARI10A
• Device Catalogue Number: BARI10A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Male