MAUDE Adverse Event Report: MOXI MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Skin Tears (2516)

Event Date 09/03/2018

Event Type  Injury  

Event Description

Cna's provided incontinent care, provided call light, bedside table within reach.Resident lying in center of mattress.Cna stated she continued bed check walked past the room , realized resident wasn't in bed, walked in room , found resident lying in the floor on her right side, called cn to room.When asked if she was hurting, resident states, "i think i broke my back." resident was moved.Ems was called immediately.Were there a injuries? yes.Was medical attention required? yes.What were the injuries? small tear to right elbow.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MOXI
• MDR Report Key: 17530543
• MDR Text Key: 321082756
• Report Number: MW5137462
• 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: Other
• Type of Report: Initial
• Report Date: 09/14/2018

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 90 YR