MAUDE Adverse Event Report: INVACARE CONTINUING CARE GROUP CS BED 9153650455; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHCS7

Device Problem Device Slipped (1584)

Patient Problem Physical Entrapment (2327)

Event Type  malfunction  

Event Description

The rails have become loose after extended use and the resident was found trapped in mattress and rails.

• Brand Name: CS BED 9153650455
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE CONTINUING CARE GROUP; OH
• Manufacturer (Section G): INVACARE CONTINUING CARE GROUP; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4395573
• MDR Text Key: 5301658
• Report Number: 3003433498-2015-00001
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHCS7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2014
• Initial Date FDA Received: 01/08/2015
• 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