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

Model Number DLPH-3582OOOOJ-M

Device Problem Pressure Problem (3012)

Patient Problem Laceration(s) (1946)

Event Date 09/25/2022

Event Type  Injury  

Manufacturer Narrative

This report or other informtion 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 daughter called to report her father fell out of a dolphin matt 4501088201.She advised the nursed were readjusting her father when he fell out of bed about 10pm (b)(6) 2022.He was taken to the emergency room at (b)(6) memorial because they could not stop the bleeding on his toe.He was given 6 stitched and has bruising on the right side of his face.Today he is sore on his shoulder and arm.Nurse practitioner amber coll ordered x-rays be done and family is still waiting for the results.Daughter was told by the facility ( doesn't remember the nurse's name) that they were adjusting the patient when the mattress malfunctioned/ deflated, and it was joerns fault not theirs.Daughter thinks there is something the facility is trying to cover up since this is not the first time something has happened to her father.Service order was created (b)(4) with notes "reported mattress deflated" (b)(4) and (b)(4) were entered into our system to have the products returned for investigation.As of this writing, the products 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: 15673659
• MDR Text Key: 302425649
• Report Number: 3009402404-2022-00028
• 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: 10/26/2022

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: 09/27/2022
• Initial Date FDA Received: 10/26/2022
• 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
• Patient Age: 86 YR