MAUDE Adverse Event Report: JOERNS HEALTHCARE DOLPHIN MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Deflation Problem (1149)

Patient Problem Pneumonia (2011)

Event Date 12/31/2021

Event Type  Death  

Event Description

Patient was on a dolphin bariatric mattress which deflated and the "blower device" used to inflate the mattress failed.The patient sunk down to the bed frame.Another blower was obtained and it worked to inflate the mattress.Patient was covid positive and critically ill with pneumonia.He succumbed to the illness on (b)(6) 2022.Fda safety report id# (b)(4).

• Brand Name: DOLPHIN MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): JOERNS HEALTHCARE
• MDR Report Key: 13281695
• MDR Text Key: 284010991
• Report Number: MW5106679
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 178 KG
• Patient Ethnicity: Hispanic
• Patient Race: White