MAUDE Adverse Event Report: AMERICAN NATIONAL AIRDYNE MATTRESS AND CONTROL UNIT; MATTRESS, FLOTATION THERAPY, NON-POWERED

Model Number MATSTD-2910-APP-AP, MATSTD-2910-AP3580

Device Problem Insufficient Information (3190)

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

Event Date 01/07/2020

Event Type  Injury  

Event Description

The patient fell off the mattress and sustained an injury to the head.Fa21.2001.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AIRDYNE MATTRESS AND CONTROL UNIT
• Type of Device: MATTRESS, FLOTATION THERAPY, NON-POWERED
• Manufacturer (Section D): AMERICAN NATIONAL
• MDR Report Key: 17528295
• MDR Text Key: 321134063
• Report Number: MW5135226
• Device Sequence Number: 1
• Product Code: IKY
• 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: 01/13/2020

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
• Device Model Number: MATSTD-2910-APP-AP, MATSTD-2910-AP3580
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1