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	12/22/2024
Type of Reportable Event	Malfunction
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 per agiliti, according to the supervisor at (b)(6) hospital in miami, patient fell off bedframe.All four siderails were up, alarm was on and alerted the floor when the patient fell.Patient was on joerns manufactured dolphin fis mattress and control unit.Agiliti will perform testing.Complaint #(b)(4) was entered into our system.

• 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: 21229858
• Report Number: 3009402404-2024-00049
• Device Sequence Number: 8534376
• Product Code: FNM
• UDI-Device Identifier: 00857268006738
• UDI-Public: 00857268006738
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/24/2025

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
• Device Model Number: DLPH-3582NCOOJ-M
• Device Catalogue Number: DLPH-3582NCOOJ-M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 01/24/2025
• 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: Other
• Patient Sex: Unknown