MAUDE Adverse Event Report: LINET SPOL. S R.O. PROTEVO GTE; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 388524

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

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

Event Date 07/03/2018

Event Type  malfunction  

Event Description

Multiple complaints of linet mattresses being uncomfortable for our patients.Chief complaint is that they are sinking into a hole in the mattress.After removing the cover and foam, it appears that the air cells do not receive adequate pressure redistribution, as the air cells flatten when weight is applied to a specific area, causing the sinking feeling.Also, we examined an arjo m-series mattress for comparison, and where you applied weight, the air cells did not flatten or cause sinking.

• Brand Name: PROTEVO GTE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): LINET SPOL. S R.O.; 13455 bobby lane; elm grove WI 53122
• MDR Report Key: 7973643
• MDR Text Key: 123988639
• Report Number: 7973643
• Device Sequence Number: 0
• Product Code: FNM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2018,09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 388524
• 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: 10/05/2018
• Date Report to Manufacturer: 10/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other