MAUDE Adverse Event Report: JOERNS HEALTHCARE DOLPHINCARE; PATIENT BED

Model Number	UCXTBED
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/21/2024
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 family called in a service to have lower rails added to her dad ucxt frame because he fell out of bed on saturday evening.Her sister woke up in the middle of the night to find their dad on the floor next to the bed.Family called the paramedics to pick him up and put him back on the dolphin system.She had placed chairs next to the frame to keep him from falling out again.She said he did not need any medical attention and he was not injured.I created stat service order (b)(4) to have the lower rails placed right away.Complaint #(b)(4) was entered into our system.

• Brand Name: DOLPHINCARE
• Common Device Name: PATIENT BED
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 20541448
• Report Number: 3009402404-2024-00044
• Device Sequence Number: 8284900
• Product Code: FNL
• UDI-Device Identifier: 00857268006004
• UDI-Public: 00857268006004
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: Lay User/Patient
• Device Model Number: UCXTBED
• Device Catalogue Number: UCXTBED
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 10/27/2024
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 150 KG