MAUDE Adverse Event Report: INVACARE INVACARE 350LB BED, MA55 36X80 MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number RC350LOW, MA55 MATTRESS, MA55 CONTROL UNIT

Device Problems Inflation Problem (1310); Inadequacy of Device Shape and/or Size (1583); Material Protrusion/Extrusion (2979)

Patient Problem Insufficient Information (4580)

Event Date 01/28/2019

Event Type  Injury  

Event Description

Air mattress is hyper inflated.Frame is too high for the patient.Believes perimeter cover on mattress does not fit appropriately.Perimeter flaps are hanging off on one side.(b)(4), (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INVACARE 350LB BED, MA55 36X80 MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17526867
• MDR Text Key: 321132207
• Report Number: MW5133804
• 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: 02/13/2019

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: RC350LOW, MA55 MATTRESS, MA55 CONTROL UNIT
• Patient Sequence Number: 1