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

Model Number	MA600
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Type of Reportable Event	Serious Injury
Event or Problem Description
Invacare was made aware on september 1, 2026, of an incident involving a 4-year-old model ma600 micro air mattress system.The pump has not operated for over a year and now the end user has developed a pressure sore on his buttocks and foot area.Before he purchased this mattress system from amazon in (b)(6) 2022, he had pressure sores, but they healed up after using the mattress.

• Brand Name: microAir Mattress
• Common Device Name: Mattress, Air Flotation, Alternating Pressure, Product Code: FNM
• Manufacturer (Section D): Caremed Supply Inc. / Prius Healthcare; 160 scarlet blvd; oldsmar FL 34677
• MDR Report Key: 50788502
• Report Number: 1531186-2026-00010
• Device Sequence Number: 9524761
• Product Code: FNM
• UDI-Device Identifier: 00841447111245
• UDI-Public: 00841447111245
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: MA600
• Device Catalogue Number: MA600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 YR
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2026
• 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: Other
• Patient Sex: Male