MAUDE Adverse Event Report: INVACARE FLORIDA OPERATIONS AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS; 880.5100

Model Number 5411IVC

Device Problem Insufficient Information (3190)

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

Event Date 02/22/2014

Event Type  Death  

Event Description

It was reported the patient was placed in a bed with a glissando gliding mattress and left unattended for an unspecified amount of time.The patient was later discovered deceased, on the floor in a seated position, with their head and neck entrapped in the bed rails.No further information was available at this time.

Manufacturer Narrative

Submission of this mdr, under this part does not constitute an admission that the device and/or any employee, caused or contributed to the reportable event.Please reference voluntary report (b)(4) for additional information.

• Brand Name: AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
• Type of Device: 880.5100
• 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: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3691303
• MDR Text Key: 4258533
• Report Number: 1031452-2014-00576
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5411IVC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2014
• 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): Death