MAUDE Adverse Event Report: MAK AND ASSOCIATES, LLC LINET PROTEVO GTE (MATTRESS), PROTEVO (PUMP); MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 1VAKSB00000M0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 03/04/2020

Event Type  malfunction  

Event Description

Patient developed reportable hospital acquired pressure injury (hapi).

• Brand Name: LINET PROTEVO GTE (MATTRESS), PROTEVO (PUMP)
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MAK AND ASSOCIATES, LLC; 13455 bobby lane; elm grove WI 53122
• MDR Report Key: 9971865
• MDR Text Key: 188046217
• Report Number: 9971865
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2020,03/31/2020

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: No Information
• Device Model Number: 1VAKSB00000M0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2020
• Device Age: 2 YR
• Date Report to Manufacturer: 04/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29930 DA