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

Model Number 900T- CU

Device Problem Improper Flow or Infusion (2954)

Patient Problem Pressure Sores (2326)

Event Date 05/03/2023

Event Type  malfunction  

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.

Event Description

It was reported to the manufacturer, by the end user, per the end user, that patient has dolphin bed for known pressure injury.Within the last 7 days there is worsening of her pressure injury due to dolphin mattress malfunction.Agiliti (equipment mgr) was called at that time to inspect mattress.They recommended unit be plugged into the wall, which was done.Rns went to patient room to follow up on wounds today, but patient was gone from her room for a procedure.Rns looked at bed whiich was again in standby.Unit was plugged in to the wall at this time.Call was made to agiliti to report this patient's bed issues and another patient in a separate room whose dolphin bed was having the same issue to have them re-check it.Device failed.Complaint #(b)(4) was entered into our system.

• 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: 17159503
• MDR Text Key: 318036213
• Report Number: 3009402404-2023-00023
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900T- CU
• Device Catalogue Number: 900T- CU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2023
• 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