MAUDE Adverse Event Report: JOERNS HEALTHCARE DOLPHIN FIS; PATIENT AIR MATTRESS

Model Number	DLPH-3582NCOOJ-M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Date of Event	12/11/2024
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 (b)(6), received a call from contact at (b)(6), that a patient had a fall that involved a bed rental.Per staff, the patient fell out of the bed.Bed exit alarm did not alarm.Patient was treated and stabilized.They placed the patient back into the bed at that time the bed exir alarm was activated and would not deactivate.Joerns is not the manufacturer of the bed frame that the patient was on but is the manufacturer of the mattress and control unit that was used on top of the bed frame.Joerns is requesting the mattress and control unit back for investigation.Complaint # (b)(4) were entered into our system to have the products returned for investigation.As of this writing, the products have not been returned.
Additional Manufacturer Narrative
This report or other information submitted by joerns healthcare under 21 cfr part 803, and 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: DOLPHIN FIS
• Common Device Name: PATIENT AIR MATTRESS
• 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: 21175771
• Report Number: 3009402404-2024-00048
• Device Sequence Number: 20968991
• Product Code: FNM
• UDI-Device Identifier: 00857268006738
• UDI-Public: 00857268006738
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/16/2025

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: Health Professional
• Device Model Number: DLPH-3582NCOOJ-M
• Device Catalogue Number: DLPH-3582NCOOJ-M
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (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 Sex: Unknown