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 Ulcer (2274)

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 technician brought the dolphin mattress on a thursday, into a retirement center.She said the mattress just felt different and hard, and she thought it was just something she needed to get used to.The facility told her it was fine.She called joerns and the technician came out and said the dolphin mattress was fine.Then called the next day, and the technician still said it was fine.The next day, after taking tylenol every 4-6 hours, the caregiver noticed she had ulcers and one was stage 4.The next day, she called joerns again and another tech came out and noticed within ten minutes noticed and explained that the other technican should have easily caught this, and no wonder she had bed sores.Nurse and can were witnesses to what the tech said.The tech had to wait outside the room to be called in.The facility she was in, they could not have her there with the bed sores, and had to go to this other facility.She gets assessed every week by the wound care nurses and doctors, and they change the bandages every day (with boric acid).She is stating that this is not her fault and this is negligence.Per facility, the patient had the ulcers prior to coming to there as well.Complaint # (b)(4) were entereed 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 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: 19085602
• MDR Text Key: 339877288
• Report Number: 3009402404-2024-00014
• 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: 04/06/2024

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: Health Professional
• Device Model Number: DLPH-3582OOOOJ-M
• Device Catalogue Number: DLPH-3582OOOOJ-M
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Female