MAUDE Adverse Event Report: INVACARE INVACARE 42X80 APM/LAL MATTRESS, MICROCAIRAPM/LAL CONTROL UNIT; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number MATSTD-MA65-P, MA65B42

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 05/15/2019

Event Type  Injury  

Event Description

Per facility employee (b)(6), patient fell out of bed earlier today, (b)(6) was unsure of the exact time.The patient did not sustain any injuries.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE 42X80 APM/LAL MATTRESS, MICROCAIRAPM/LAL CONTROL UNIT
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17525684
• MDR Text Key: 321057688
• Report Number: MW5132625
• 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: 05/21/2019

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: MATSTD-MA65-P, MA65B42
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1