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

Model Number DLPH-3582OOOOJ-M

Device Problem Infusion or Flow Problem (2964)

Patient Problem Fall (1848)

Event Date 05/12/2023

Event Type  Injury  

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 Description

It was reported to the manufacturer, by the end user, per the end user, that md stated that on (b)(6) 2023 at around 9:25 am ,he fell onto the floor from his bed and was carried to the hospital ,upon examination it was determined his left ankle was broken in two places and the index finger on his right hand was broken.Md states that his mattress did not feel has firm has it usually is.Md informed me of the incident today at a service ride for the fault light coming on for the mattress.Complaint #(b)(4) and ra #(b)(4) were entered into our system to have the products returned for investigation.

• Brand Name: DOLPHIN FIS
• Type of Device: 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: 17143977
• MDR Text Key: 317457459
• Report Number: 3009402404-2023-00022
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/16/2023

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 Operator: Lay User/Patient
• Device Model Number: DLPH-3582OOOOJ-M
• Device Catalogue Number: DLPH-OOOOOODMJ-CU
• Device Lot Number: 1000138629
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/16/2023
• 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): Hospitalization; Other
• Patient Sex: Male