MAUDE Adverse Event Report: PYRAMID AIR MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 12/28/2022

Event Type  Death  

Event Description

Resident found with bottom half of body on floor and head/neck wedged between mattress and bedrail, found deceased.

• Brand Name: PYRAMID AIR MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• MDR Report Key: 16086055
• MDR Text Key: 306595900
• Report Number: MW5114100
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White