MAUDE Adverse Event Report: AMERICAN NATIONAL AMERICAN NATIONAL AIRDYNE CONTROL UNIT AND DYNAMAX MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 08/20/2019

Event Type  Injury  

Event Description

Joerns received a call from ednalyn from the facility asking for a lal mattress with bolsters to replace the mattress that the patient was on currently due to the fact that the patient fell from the bed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AMERICAN NATIONAL AIRDYNE CONTROL UNIT AND DYNAMAX MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): AMERICAN NATIONAL
• MDR Report Key: 17537485
• MDR Text Key: 321148111
• Report Number: MW5144363
• 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: 09/06/2019

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