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

Model Number 900T-3582-M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fall (1848)

Event Date 08/07/2023

Event Type  Death  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that received an email from wcn at (b)(6) that a patient incident occurred on an agiliti rental.The patient ws being prepped for hospice and fell out of bed which resulted in death.Complaint #(b)(4) and ra #(b)(4) was entered into our system to have the mattress and control unit returned for investigation.

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.

• 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: 17711690
• MDR Text Key: 322971717
• Report Number: 3009402404-2023-00032
• 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: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 900T-3582-M
• Device Catalogue Number: 900T-3582-M
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/07/2023
• 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): Death