MAUDE Adverse Event Report: CARROLL HEALTHCARE AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS; 880.5100

Model Number SOLO

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/22/2014

Event Type  Death  

Event Description

It was reported that the patient expired after slipping out of the solo bed and catching her chin on the bottom of the upper side rail entrapping her neck.The facility reported that the rail was in the down guard position but allegedly not at the correct height.In addition, the patient orders indicated that the patient should not have had rails on the bed.Facility indicated that the incident was not a result of the bed malfunctioning.

Manufacturer Narrative

The initial reporter indicated that a report was submitted to the fda, however, at the time of this filing the manufacturer has not received such report.

• Brand Name: AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS
• Type of Device: 880.5100
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, ontario N6E 1P5; CA N6E 1P5
• Manufacturer (Section G): CARROLL HEALTHCARE; 994 hargrieve rd; london, ontario N6E 1P5; CA N6E 1P5
• Manufacturer Contact: gregory stevens ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 3714889
• MDR Text Key: 4331152
• Report Number: 3003433498-2014-00041
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: SOLO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 03/31/2014
• 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
• Patient Age: 94
• Patient Weight: 54