MAUDE Adverse Event Report: APM MATTRESS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 02/13/2023

Event Type  Injury  

Event Description

Malfunction with dme provider's airmattress.Airmattress did not operate appropriately and the patient was found in a deflated mattress and has a new pressure wound to her back.

• Brand Name: APM MATTRESS
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• MDR Report Key: 16399512
• MDR Text Key: 309905556
• Report Number: MW5115037
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/14/2023

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White