MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS ALTERNATING PRESSURE AIR FLOTATION MATTRESS; 880.5550

Model Number BB9612000

Device Problem Positioning Problem (3009)

Patient Problem Pressure Sores (2326)

Event Type  malfunction  

Event Description

The dealer alleges that the mattress is sinking in the middle, and the end user has developed bed sores from this.There is no indication of medical treatment to prevent or preclude permanent impairment of a body structure or function.No additional information provided.

• Brand Name: ALTERNATING PRESSURE AIR FLOTATION MATTRESS
• Type of Device: 880.5550
• Manufacturer (Section D): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer (Section G): INVACARE FLORIDA OPERATIONS; 2101 east lake mary blvd; sanford FL 32773
• Manufacturer Contact: karen loughren ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4041784
• MDR Text Key: 4905930
• Report Number: 1031452-2014-07423
• 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: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 08/04/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BB9612000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other