MAUDE Adverse Event Report: Caremed Supply Inc. / Prius Healthcare microAir Mattress; Mattress, Air Flotation, Alternating Pressure

Model Number	MA800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Invacare was made aware on july 23, 2026, of an incident involving a 2-year-old model ma800 micro air mattress system.The end-user stated that sometimes the air goes in between the cells and there is a sink in spot in the mattress.After using this mattress for a year, the end user has developed a pressure wound on the left side of his hip.He originally had a lateral rotation mattress because of an open wound on the left hip that did close but has reopened since using the new alternating pressure mattress.
Additional Manufacturer Narrative
The subject mattress system was manufactured in june 2024.The end user is paraplegic and has used this mattress for a year.He weighs 188lbs and is within the product weight capacity of 600lbs.The end user has been going to wound care prior to this incident.This mattress is an alternating unit that every 3 cells will deflate and inflate per cycle time setting.It is unclear if there is a defect in the mattress.The microair ma800 mattress system user manual provides a caution, "repositioning of the patient is always recommended when using an alternating pressure air mattress." at this time a return is not anticipated.If additional information is received, a follow-up will be filed.

• Brand Name: microAir Mattress
• Common Device Name: Mattress, Air Flotation, Alternating Pressure
• Manufacturer (Section D): Caremed Supply Inc. / Prius Healthcare; 160 scarlet blvd; oldsmar FL 34677
• MDR Report Key: 50323966
• Report Number: 50323966
• Device Sequence Number: 9596486
• Product Code: FNM
• UDI-Device Identifier: 00841447111252
• UDI-Public: 00841447111252
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2026
• Report Date (Section F): 08/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MA800
• Device Catalogue Number: MA800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2026
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 08/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 188 LB