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

Model Number DLPH-3582NCDMU-KIT

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2023

Event Type  malfunction  

Manufacturer Narrative

This report or other informtion 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 Description

It was reported to the manufacturer, by the end user, per the end user, that patient was on a dolphin mattress and blower, units malfunctioned, and the patient was on the frame.Units were swapped out for a different dolphin mattress and blower which led to another malfunction and the patient was on the frame again.Complaint (b)(4) and ra (b)(4) were entered into our system to have the units returned for investigation.As of this writing, the units have not been returned.

• Brand Name: DOLPHIN FIS
• Type of Device: PATIENT AIR MATTRES
• 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: 18222551
• MDR Text Key: 329578182
• Report Number: 3009402404-2023-00044
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DLPH-3582NCDMU-KIT
• Device Catalogue Number: DLPH-3582NCDMU-KIT
• Device Lot Number: 1000366988
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other