MAUDE Adverse Event Report: INVACARE MICROAIR APM/LAL PUMP, MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number INVACARE MA65-P MICROAIR APM/LAL PUMP, MATTRESS MA65 48X80 BARI APM/LAL

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

Patient Problem Fall (1848)

Event Date 03/16/2021

Event Type  Injury  

Event Description

Patient leg was too close to edge and slipped off the mattress.No injuries occurred.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MICROAIR APM/LAL PUMP, MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17536792
• MDR Text Key: 321061327
• Report Number: MW5143676
• 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: 04/16/2021

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
• Device Model Number: INVACARE MA65-P MICROAIR APM/LAL PUMP, MATTRESS MA65 48X80 BARI APM/LAL
• Device Catalogue Number: MATSTD-MA65-P, MA65B48
• Patient Sequence Number: 1