MAUDE Adverse Event Report: INVACARE INVACARE 36X80 APM/LAL MATTRESS, MICROCAIRAPM/LAL CONTROL UNIT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number MA65 3680

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 08/25/2019

Event Type  Injury  

Event Description

Marilyn with facility placed delivery order with the following note: "need replacement to what he has right now which is ma65 3680.The resident just fell off the bed." per anna umanski, patient reports that he slid off mattress at 3am., that one leg slid off bed and then the rest of him fell off.No injuries were reported and there were no witnesses.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE 36X80 APM/LAL MATTRESS, MICROCAIRAPM/LAL CONTROL UNIT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17535181
• MDR Text Key: 321158484
• Report Number: MW5142081
• 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: 09/04/2019

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
• Device Model Number: MA65 3680
• Patient Sequence Number: 1
• Patient Age: 81 YR