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

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 05/11/2018

Event Type  Death  

Event Description

Patient rolled out of the bed and hit her head.The mattress was still inflated.That is all the information that (b)(6) has.Were there any injuries?: yes.Was medical attention required? yes.What were the injuries?: patient hit her head went to the hospital and died from injury.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: 17535784
• MDR Text Key: 321039924
• Report Number: MW5142678
• 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: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR