MAUDE Adverse Event Report: INVACARE 1)INVACARE 36X80 AMP/LAL MATTRESS; 2) MICROAIR APM/LAL CONTROL UNIT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 1) MATSTD_MA65-P; 2) MATSTD-MA65M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 02/20/2020

Event Type  Injury  

Event Description

The patient fell out of the bed.There were no serious injuries.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: 1)INVACARE 36X80 AMP/LAL MATTRESS; 2) MICROAIR APM/LAL CONTROL UNIT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17525647
• MDR Text Key: 321057621
• Report Number: MW5132588
• 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: 03/04/2020

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: 1) MATSTD_MA65-P; 2) MATSTD-MA65M
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 67 YR