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

Model Number DLPH-3582OOOOJ-M

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  malfunction  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that patient in room 212 fell off dolphin mattress in late hours of last night per wound care nurse.No injuries to report at this time.Upon arrival to the facility, fst witnessed a fault light on the control unit, mattress not completely inflated, cpr plug was damaged to unserviceable state.It appeared to have been crushed against the headboard in up and down function.Fall pads were in place and frame was no more estimated than 14 inches off the ground.Mattress and control unit were exchanged and gener bolster set was placed between the mattress and cover, upon request of the wound care nurse.Complaint #(b)(4) and ra#(b)(4) was entered into our system to have the mattress and control unit 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: 11869052
• MDR Text Key: 252195772
• Report Number: 3009402404-2021-00005
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DLPH-3582OOOOJ-M
• Device Catalogue Number: DLPH-3582OOOOJ-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2021
• 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