MAUDE Adverse Event Report: LINET LLC PROTEVO GTE+ MCM; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problems Crack (1135); Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2019

Event Type  malfunction  

Event Description

Air hose connector to mattress had crack and bed was not inflating to protect patient's skin.Patient already had preexisting sacrum wound.

• Brand Name: PROTEVO GTE+ MCM
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): LINET LLC; 13455 bobby lane; elm grove WI 53122
• MDR Report Key: 9191049
• MDR Text Key: 162343666
• Report Number: 9191049
• 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: 09/26/2019,09/25/2019

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2019
• Date Report to Manufacturer: 10/10/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 82