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

Model Number DLPH-3582OODMJ-KIT

Device Problems Inadequate or Insufficient Training (1643); Activation, Positioning or Separation Problem (2906)

Patient Problem Pain (1994)

Event Date 12/23/2021

Event Type  Injury  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that mattress was delivered on (b)(6) 2021 and the tech did not stop to advise or give any education on how to operate the equipment.Facility further states, they were not provided an instruction manual.Tech came out for service on 12/22/2021 and they did not know what was done as the tech did not speak to a member of management.States they found straps were broken as the tech placed the mattress without strapping it down and when asked the tech advised the mattress would not move.The mattress turned the resident over, when the mattress deflated on the edge behind the patient which caused him to fall.Complaint (b)(4) was entered into our system to have the bed, mattress and control unit returned for investigation.As of this writing, the units have not been returned.

• Brand Name: DOLPHIN CARE
• 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: 13387474
• MDR Text Key: 286943373
• Report Number: 3009402404-2021-00028
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DLPH-3582OODMJ-KIT
• Device Catalogue Number: DLPH-3582OODMJ-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• 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): Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic