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 Problems Fall (1848); Pain (1994)

Event Date 02/21/2020

Event Type  Injury  

Event Description

1:40 am on (b)(6) 2020, patient lying on the carpeted floor on her right side with pain 8/10.Facility staff asked if she wanted to get up , as per patient said, no, i just slid.She hit her head and axo to name with confusion.She thinks she may have fracture.Patient sent to kaiser walnut creek via 911.(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: 17533272
• MDR Text Key: 321152069
• Report Number: MW5140176
• 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: 83 YR