MAUDE Adverse Event Report: INVACARE INVACARE GLISSANDO GLIDING MATTRESS; FOAM MATTRESS

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Fall (1848); Physical Entrapment (2327)

Event Date 02/22/2014

Event Type  Death  

Event Description

The rails were portable and / or clamped.Two rails used: upper i.E.Head or top rails.Name and type of mattress in use with bed: invacare glissando gliding mattress.Foam mattress.Head and neck entrapped in bottom of the top bed rail on the left-side of the bed.Resident was found in sitting position on the floor with the bottom of her chin resting on the bottom bar of the top rail, neck was hyper-extended at approx 5:45 am on (b)(6) 2014.Date purchased: unknown.Attending health professional: doctor (b)(6).

• Brand Name: INVACARE GLISSANDO GLIDING MATTRESS
• Type of Device: FOAM MATTRESS
• Manufacturer (Section D): INVACARE; *
• MDR Report Key: 3673286
• MDR Text Key: 4298219
• Report Number: MW5034885
• Device Sequence Number: 2
• Product Code: IKY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Death